ЯДРА МИКРОПЕЛЛЕТ ПАНКРЕАТИНА, ПРИГОДНЫЕ ДЛЯ НАНЕСЕНИЯ ЭНТЕРОСОЛЮБИЛЬНОГО ПОКРЫТИЯ

В заявке описаны способ получения и применения ядер микропеллет панкреатина и ядра микропеллет панкреатина, получаемые этим способом, которые не содержат синтетических масел. В заявке также описаны содержащие энтеросолюбильное покрытие микропеллеты панкреатина. Изобретение обеспечивает улучшенный способ получения микропеллет панкреатина с энтеросолюбильным покрытием, которые могут поступать на оптимальный участок пищеварительного тракта, на котором необходимо воздействие пищеварительного фермента, в частности, в верхний отдел кишечника для высвобождения панкреатина. 6 н. и 11 з.п. ф-лы, 3 табл.

НОВЫЕ МОДУЛЯТОРЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ

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СТАБИЛИЗАТОР ДЛЯ ГИАЛУРОНИДАЗЫ И ЖИДКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ГИАЛУРОНИДАЗУ

Изобретение относится к стабильной водной композиции, содержащей гиалуронидазу, стабилизатор для гиалуронидазы и воду в качестве растворителя. Гиалуронидаза экстрагирована из семенников одного или более млекопитающих, исключая человека, и имеет чистоту 95% или более и специфическую активность 70000 МЕ/мг или более. Стабилизатор гиалуронидазы состоит из буферного агента для обеспечения рН от 4,0 до 6,0, неионного поверхностно-активного вещества от 0,001 до 0,01 об./об.% и от 0,1 до 1 мМ этилендиаминтетрауксусной кислоты в качестве хелатообразующего агента или МgCl. Гиалуронидаза очищена от содержащего гиалуронидазу материала способом аффинной хроматографии, ионообменной хроматографии или гель-фильтрации. Водная композиция гиалуронидазы по изобретению характеризуется улучшенной стабильностью и может заменить лиофилизированные композиции гиалуронидазы. 2 н. и 16 з.п. ф-лы, 8 ил., 21 табл., 8 пр.

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ГИАЛУРОНИДАЗА И СПОСОБ ЕЕ ПРИМЕНЕНИЯ

Изобретение относится к биотехнологии и медицине и представляет собой фармацевтический состав для расщепления гиалуроновой кислоты in vivo, содержащий эффективное количество выделенного белка гиалуронидазы, который имеет молекулярный вес 44±1 кДа и содержит аминокислотную последовательность, по меньшей мере на 90% идентичную последовательности SEQ ID NO: 1, SEQ ID NO: 2 и SEQ ID NO: 4, и фармацевтически приемлемый эксципиент, носитель, разбавитель или вспомогательный агент. Изобретение относится также к способу минимизации проявления рубца, включающему местное применение такого фармацевтического состава, а также к способу повышения терапевтической эффективности лекарственного средства, включающему введение пациенту лекарственного средства совместно с фармацевтическим составом. Изобретение позволяет расширить ассортимент средств для улучшения проникновения одновременно вводимого активного вещества через кожу. 7 н. и 35 з.п. ф-лы, 16 ил., 23 табл., 12 пр.

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ТЕРАПЕВТИЧЕСКОЕ СРЕДСТВО ОТ ГРЫЖИ МЕЖПОЗВОНОЧНОГО ДИСКА

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КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ ЛЕЧЕНИЯ БОЛЕЗНИ ГОШЕ

Группа изобретений относится к определению продукции нейтрализующих антител у субъектов, проходящих лечение болезни Гоше. Раскрыт способ детекции нейтрализующего антитела против глюкоцереброзидазы в образце от субъекта, включающий иммобилизацию глюкоцереброзидазы на поверхность; приведение образца в контакт с иммобилизованной глюкоцереброзидазой; стадию промывки; добавление меченой глюкоцереброзидазы; стадию промывки для удаления меченой глюкоцереброзидазы, которая не связалась с антителом против глюкоцереброзидазы; обнаружение и количественную оценку метки; оценку присутствия специфического изотипа антитела против глюкоцереброзидазы, где изотип выбран из группы, состоящей из IgG, IgM, IgA и IgE, и определение, нейтрализует ли антитело против глюкоцереброзидазы активность глюкоцереброзидазы, с использованием клеток, которые экспрессируют человеческие рецепторы макрофагов против маннозы (MMR). Также раскрыт способ идентификации субъекта, для которого будет эффективно лечение болезни Гоше ...

ПРЕДОТВРАЩЕНИЕ, РАЗРУШЕНИЕ И ОБРАБОТКА БИОПЛЕНКИ ЛИЗИНОМ БАКТЕРИОФАГА

Группа изобретений относится к способам для предотвращения образования, а также разрушения или эрадикации биопленок грам-положительных бактерий. Предложены способ предотвращения, разрушения или эрадикации биопленки, включающей одну или более из бактерий Staphylococcus и Streptococcus, и способ профилактики или лечения инфекции, ассоциированной с биопленкой у субъекта, включающей одну или более из бактерий Staphylococcus и Streptococcus. Способы включают приведение биопленки в контакт с композицией, содержащей измененный литический фермент, включающий домен SH-3 PlySs2, содержащий аминокислотную последовательность SEQ ID NO: 4 или ее вариант, обладающий по меньшей мере 80% идентичностью с SEQ ID NO: 4 и являющийся эффективным для связывания Staphylococcus и Streptococcus в биопленке, и каталитический домен, представляющий собой домен CHAP лизина стрептококковых или стафилококковых фагов. Изобретения позволяют устранять не только зрелые биопленки, но и предотвращать образование биопленок ...

КОМБИНАЦИЯ ФАКТОРОВ РОСТА, ЦИТОКИНОВ, АНТИБАКТЕРИАЛЬНЫХ/АНТИВИРУСНЫХ ФАКТОРОВ, ФАКТОРОВ СТВОЛОВЫХ КЛЕТОК, БЕЛКОВ КОМПЛЕМЕНТА С3А/С4А, ИММУНОГЛОБУЛИНОВ И ХЕМОТАКСИЧЕСКИХ ФАКТОРОВ

Изобретение относится к фармацевтической промышленности, а именно к комбинации и фармацевтической композиции для лечения заболеваний, требующих восстановления и регенерации тканей. Комбинация цитокинов, факторов роста, хемотаксических факторов, факторов стволовых клеток, белкового комплемента, иммуноглобулинов и антибактериальных/антивирусных факторов, взятых в определенном соотношении и с определенным составом компонентов, для лечения заболеваний, требующих восстановления и регенерации тканей. Фармацевтическая композиция для лечения заболеваний, требующих восстановления и регенерации тканей. Вышеописанные комбинация и фармацевтическая композиция позволяют эффективно восстанавливать и регенерировать ткани. 2 н. и 7 з.п. ф-лы, 2 ил., 11 табл., 9 пр.

ГИАЛУРОНИДАЗА И СПОСОБ ЕЕ ПРИМЕНЕНИЯ

Изобретение относится к области биохимии. Представлены выделенный белок гиалуронидазы, который имеет молекулярный вес приблизительно 44±1 кДа, содержащий аминокислотную последовательность, по меньшей мере, на 90% идентичную последовательности, которая содержит SEQ ID NO: I, SEQ ID NO: 2 и SEQ ID NO: 4, приведенные в описании, а также кодирующая его ДНК. Описан фармацевтический лекарственный состав для повышения проницаемости ткани или уменьшения вязкости соединительной ткани, содержащий эффективное количество выделенной указанной гиалуронидазы и фармацевтически приемлемый эксципиент, носитель, разбавитель или вспомогательный агент. Предложены способы: 1) предотвращения или минимизации образования рубца, включающий местное введение указанного фармацевтического состава; 2) сокращения проявления морщин посредством уменьшения вязкости соединительной ткани, включающие местное введение указанного фармацевтического состава; 3) облегчения дискомфорта или боли, вызванной ревматическим артритом, ...

ПРИМЕНЕНИЕ ГИАЛУРОНИДАЗЫ ДЛЯ ПРОФИЛАКТИКИ ИЛИ ЛЕЧЕНИЯ АРТЕРИАЛЬНОЙ ГИПЕРТЕНЗИИ ИЛИ СЕРДЕЧНОЙ НЕДОСТАТОЧНОСТИ

Предложены: применение гиалуронидазы для профилактики и/или лечения артериальной гипертензии, соответствующий способ лечения или профилактики артериальной гипертензии. Также предложены состав, комбинированный препарат и фармацевтическая композиция для профилактики и/или лечения артериальной гипертензии, содержащие гиалуронидазу и по меньшей мере одно дополнительное антигипертензивное средство, и способ профилактики и/или лечения артериальной гипертензии с их использованием. Показано достижение заявленного назначения при самостоятельном введении гиалуронидазы и усиление под действием гиалуронидазы гипотензивного действия ингибиторов ангиотензина II, антагониста кальциевого канала, антагониста АПФ и комбинаций антигипертензивных средств. 7 н. и 9 з.п. ф-лы, 10 табл., 4 пр.

ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ФЕРМЕНТ, РАЗРУШАЮЩИЙ ГЛИКОЗАМИНОГЛИКАНЫ, И ПРИМЕНЕНИЕ УКАЗАННОГО ФЕРМЕНТА ДЛЯ ПОЛУЧЕНИЯ ЛЕКАРСТВЕННОГО ПРЕПАРАТА ДЛЯ ТЕРАПИИ ГРЫЖИ МЕЖПОЗВОНОЧНОГО ДИСКА

Изобретение может быть использовано в медицине, а именно для терапии грыжи межпозвоночного диска. Фармацевтическая композиция для введения в вертебральное эпидуральное пространство включает фермент, разрушающий гликозаминогликаны, и фармацевтический носитель. Также изобретение относится к применению фермента, разрушающего гликозаминогликаны, в качестве лекарственного препарата для терапии грыжи межпозвоночного диска, который характеризуется наличием в эпидуральном пространстве студенистого ядра, где указанный препарат вводится в вертебральное эпидуральное пространство. Изобретение повышает эффективность терапии грыжи межпозвоночного диска. 2 с. и 11 з.п.ф-лы, 1 табл., 1 ил.

АДЕНОАССОЦИИРОВАННЫЕ ВИРУСНЫЕ ВЕКТОРЫ ДЛЯ ЛЕЧЕНИЯ ЛИЗОСОМНЫХ БОЛЕЗНЕЙ НАКОПЛЕНИЯ

Изобретения относятся к аденоассоциированным вирусным векторам и содержащим их фармацевтическим композициям для лечения лизосомных болезней накопления, и в частности для лечения мукополисахаридозов типа IIIВ (MPSIIIB). Предложен рекомбинантный AAV9-вектор, содержащий промотор CAG, SEQ ID NO: 4, связанный с нуклеотидной последовательностью, кодирующей альфа-N-ацетилглюкозаминидазу, SEQ ID NO: 1, причем нуклеотидная последовательность, кодирующая альфа-N-ацетилглюкозаминидазу, SEQ ID NO: 1, представляет собой последовательность SEQ ID NO: 3, SEQ ID NO: 19 или SEQ ID NO: 22 и последовательность полиА, вставленную между первым концевым повтором AAV и вторым концевым повтором AAV. Предложена также плазмида, содержащая нуклеотидную последовательность, кодирующую альфа-N-ацетилглюкозаминидазу, SEQ ID NO: 1. Причем указанная плазмида представляет собой либо pAAV-CAG-cohNaglu с номером доступа DSM 26626, содержащая нуклеотидную последовательность SEQ ID NO: 3, кодирующую альфа-N-ацетилглюкозаминидазу ...

СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ДОСТАВКИ В ЦНС АРИЛСУЛЬФАТАЗЫ А

Группа изобретений относится к фармацевтической промышленности, а именно к применению состава, содержащего белок арилсульфатазу А (ASA), для изготовления лекарственного средства для лечения болезни метахроматической лейкодистрофии (МЛД). Предложено применение состава, содержащего белок арилсульфатазу А (ASA), для изготовления лекарственного средства для лечения болезни метахроматической лейкодистрофии (МЛД), причем указанный белок ASA присутствует в составе в концентрации от по меньшей мере 5 до 50 мг/мл, при этом указанный состав содержит фосфат в количестве не более 10 мM, и при этом указанный состав вводится интрацеребровентрикулярно (ИЦВ). А также предложено применение состава, содержащего белок арилсульфатазу А (ASA) и фармацевтические приемлемое вспомогательное вещество, для изготовления лекарственного средства для лечения болезни метахроматической лейкодистрофии (МЛД), причем указанный белок ASA присутствует в составе в концентрации 30 мг/мл, и при этом указанный состав содержит ...

Способ проведения тромболиза при нарушениях кровообращения в глазном яблоке и ретробульбарном пространстве (варианты)

Группа изобретений относится к медицине, а именно к офтальмологии, и может быть использована для проведения тромболиза при нарушениях кровообращения в глазном яблоке и ретробульбарном пространстве. Способы по изобретению включают введение посредством ванночкового электрофореза в ткани глазного яблока и ретробульбарного пространства ферментных препаратов для растворения формирующихся и сформированных тромбов в кровеносных сосудах глазного яблока и орбиты. При этом в качестве ферментного препарата используют лидазу, гемазу и химотрипсин. Использование группы изобретений позволяет сократить время восстановления кровотока в сосуде за счет лизиса тромба внутри сосудистого русла в глазном яблоке и ретробульбарном пространстве без определения типа тромба и его локализации. 3 н.п. ф-лы, 6 пр.

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Настоящее изобретение относится к области медицины, а именно к способу получения ранозаживляющего геля, содержащего трипсин, для наружного применения, заключающемуся в перемешивании 16,6%-ного водного раствора желатина, разогретого при температуре 60°C, 2%-ного водного раствора альгината натрия, разогретого при температуре 80°C, после охлаждения до температуры 30°C при постоянном перемешивании добавляют 16,6%-ный водный раствор фермента трансглутаминазы, глицерин, трипсин и фузидин, получают гелеобразующую смесь, при следующем соотношении компонентов, мас.%: водный раствор желатина 30,5 – 32,5, водный раствор альгината натрия 32,5 – 34,5, водный раствор фермента трансглутаминазы 30,5 – 32,5, глицерин 0,9 – 1,1, трипсин 1,0 – 1,3, фузидин 0,1 – 0,2. Настоящее изобретение обеспечивает ускорении процесса заживления кожных ран за счет кровоостанавливающего, ранозаживляющего и антисептического действия ранозаживляющего геля, которое наступает без образования рубцов, а также низкой адгезии к ...

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Изобретение относится к медицине, а именно к фармацевтической промышленности, и касается лекарственных форм (ЛФ) в виде геля и спрея для лечения или профилактики раневых и госпитальных инфекций. Лекарственное средство для лечения или профилактики госпитальных и раневых инфекций содержит смесь рекомбинантных эндолизинов LysECD7, LysAm24 и LysAp22 в концентрации 0,03-0,15 мас.% и вспомогательные компоненты. При этом средство в форме геля содержит гелеобразователь, ПЭГ 1500 или ПЭГ 3000 и буферный раствор с рН 7,0-8,0. Лекарственное средство в форме спрея содержит Полоксамер 338 или Полоксамер 407, ПЭГ 1500 или ПЭГ 3000 и буферный раствор с рН 7,0-8,0. Лекарственные средства обеспечивают местное антибактериальное действие путем нанесения их на раневую поверхность или введения в полость абсцесса, обладают широким спектром действия, не влияя на представителей нормофлоры ЖКТ. 2 н.п. ф-лы, 4 ил., 9 табл., 6 пр.

НОВЫЕ ОФТАЛЬМОЛОГИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РЕКОМБИНАНТНЫЙ ЧЕЛОВЕЧЕСКИЙ ЛИЗОЦИМ, И ИХ ПРИМЕНЕНИЕ ДЛЯ ЛЕЧЕНИЯ СОСТОЯНИЙ ГЛАЗ И В КАЧЕСТВЕ РАСТВОРОВ ДЛЯ КОНТАКТНЫХ ЛИНЗ

... 1. Офтальмологический раствор, содержащий: ! a) содержимое в виде рекомбинантного человеческого лизоцима; ! b) одно или более природных лакрофильных веществ; ! c) воду; и ! d) необязательно одно или более терапевтических веществ. ! 2. Офтальмологический раствор по п.1, который содержит приблизительно от 0,01 до приблизительно 5 мас.% рекомбинантного человеческого лизоцима. ! 3. Офтальмологический раствор по п.2, который содержит приблизительно от 0,1 до приблизительно 1 мас.% рекомбинантного человеческого лизоцима. ! 4. Офтальмологический раствор по п.1, который содержит одно или более природных лакрофильных веществ, выбранных из группы, состоящей из аскорбиновой кислоты, лимонной кислоты, борной кислоты и этилендиаминтетрауксусной кислоты и физиологически приемлемых солей указанных кислот. ! 5. Офтальмологический раствор по п.4, который содержит приблизительно от 0,01 до приблизительно 15 мас.% аскорбиновой кислоты или ее физиологически приемлемой соли. ! 6. Офтальмологический раствор ...

ПРЕДОТВРАЩЕНИЕ, РАЗРУШЕНИЕ И ОБРАБОТКА БИОПЛЕНКИ ЛИЗИНОМ БАКТЕРИОФАГА

... 1. Способ предотвращения, разрушения или обработки биопленки грамположительных бактерий, включающий контактирование биопленки с композицией, содержащей полипептид лизина, способный к лизису стафилококков, где биопленку эффективно предотвращают, диспергируют или обрабатывают.2. Способ по п. 1, где полипептид лизина представляет собой PlySs2.3. Способ по п. 2, где полипептид лизина содержит аминокислотную последовательность, представленную на ФИГУРЕ 5 (SEQ ID NO: 1) или ее варианты, имеющие по меньшей мере 80% идентичности с полипептидом ФИГУРЫ 5 (SEQ ID NO: 1), и является эффективным для лизиса грамположительных бактерий в биопленке.4. Способ по п. 1, где композиция дополнительно содержит один или несколько антибиотиков.5. Способ по п. 4, где антибиотик выбирают из даптомицина, ванкомицина и линезолида.6. Способ по п. 1, дополнительно включающий контактирование биопленки с одним или несколькими антибиотиками.7. Способ предотвращения или снижения образования биопленки грамположительных бактерий ...

БЕТА-ПРОПИОЛАКТОН ДЛЯ ИНАКТИВАЦИИ ВИРУСОВ В ФАРМАЦЕВТИЧЕСКИХ ПРЕПАРАТАХ ФЕРМЕНТА ПОДЖЕЛУДОЧНОЙ ЖЕЛЕЗЫ

... 1. Препарат фермента поджелудочной железы (PEP), обладающий сниженной вирусной инфекционностью, содержащий (i) один или несколько ферментов поджелудочной железы и (ii) 3-гидроксипропионовую кислоту, бета-пропиолактон (BPL) или их смесь.2. Препарат фермента поджелудочной железы по п.1, содержащий (i) один или несколько ферментов поджелудочной железы и (ii) 3-гидроксипропионовую кислоту.3. Препарат фермента поджелудочной железы по п.1, где препарат был предварительно обработан бета-пропиолактоном (BPL) и имеет вирусную инфекционность свиного парвовируса (PPV) по меньшей мере на 1 log ниже таковой в препарате, не обработанном BPL.4. Препарат фермента поджелудочной железы по п.1, где препарат был предварительно обработан бета-пропиолактоном (BPL) и имеет вирусную инфекционность вирусов без оболочки по меньшей мере на 1 log ниже таковой в препарате, не обработанном BPL.5. Препарат фермента поджелудочной железы по п.1, где препарат был предварительно обработан бета-пропиолактоном (BPL) и имеет ...

СПОСОБ ПОЛУЧЕНИЯ ТЕТРАНЕКТИН-АПОЛИПОПРОТЕИН А-I ЧАСТИЦЫ, ПОЛУЧЕННАЯ ТАКИМ ОБРАЗОМ ЛИПИДНАЯ ЧАСТИЦА И ЕЕ ПРИМЕНЕНИЕ

... 1. Способ получения липидной частицы, включающий следующие стадии:i) получение первого раствора, включающего денатурированный белок,ii) добавление первого раствора ко второму раствору, содержащему по меньшей мере один липид и детергент, но не содержащему белка, иiii) удаление детергента из раствора, полученного на стадии ii), с получением липидной частицы.2. Способ по п.1, отличающийся тем, что второй раствор имеет объем, составляющий примерно от 3 до примерно 20 объемов первого раствора.3. Способ по п.1, отличающийся тем, что первый раствор свободен от липидов.4. Способ по п.1, отличающийся тем, что указанный белок имеет аминокислотную последовательность, выбранную из следующих аминокислотных последовательностей: SEQ ID NO:01, 02, 04-52, 66 или 67, или же включает по меньшей мере непрерывный фрагмент, включающий по меньшей мере 80% аминокислотной последовательности SEQ ID NO:01, 02, 04-52, 66 или 67.5. Способ по п.4, отличающийся тем, что указанный белок представляет собой тетранектин-аполипопротеин ...

КОМПОЗИЦИЯ ДЛЯ УХОДА ЗА ПОЛОСТЬЮ РТА И СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ

... 1. Композиция для ухода за полостью рта, содержащая:носитель, включающий растворитель;множество ферментов, выбранных из группы, состоящей из лизоцима, амилазы, амилоглюкозидазы, глюкозидазы, пептизима и папаина; икомпозицию для обезвреживания ионов металлов, включающую одно или более чем одно соединение, выбранное из группы, состоящей из натриевой соли ЭДТА (этилендиаминтетрауксусная кислота), фитиновой кислоты и лактоферрина.2. Композиция для ухода за полостью рта по п.1, дополнительно содержащая глюконат цинка.3. Композиция для ухода за полостью рта по п.1, дополнительно содержащая лактат кальция.4. Композиция для ухода за полостью рта по п.1, где растворитель включает дистиллированную воду, пропиленгликоль и сорбит.5. Композиция для ухода за полостью рта по п.1, где носитель включает загуститель, выбранный из группы, состоящей из пропандиола, карбоксиметилцеллюлозы, целлюлозной смолы, поливинилпирролидона, гидроксиэтилцеллюлозы, ксантановой камеди и их комбинаций.6. Композиция для ухода ...

НОВЫЕ МОДУЛЯТОРЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ

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Антибактериальная композиция (варианты) и применение белка в качестве антимикробного средства, направленного против бактерий Acinetobacter baumannii, (варианты)

Изобретение относится к области биотехнологии, конкретно к терапевтическим белкам, и может быть использовано в медицине в качестве антибактериального средства. Предложено использование белка рекомбинантного эндолизина бактериофага, в том числе в комбинации с фармацевтически приемлемыми носителями и/или веществами, увеличивающими проницаемость мембран, в качестве антимикробного средства, направленного против бактерий Acinetobacter baumannii. На основе указанного белка, в том числе слитого с 8-гистидиновой меткой, получены антибактериальные композиции. Изобретение обеспечивает эффективное проникновение эндолизина без добавления различных пермеабилизаторов или ковалентно связанных пенетрирующих пептидов через наружную мембрану указанных бактерий и расщепление пептидогликана, что в конечном итоге приводит к гибели бактерий. 4 н.п. ф-лы, 3 табл., 6 пр., 5 ил.

ПРИМЕНЕНИЕ ПОРИСТЫХ МАТЕРИАЛОВ ДЛЯ ИНГИБИРОВАНИЯ/НАРУШЕНИЯ ЧУВСТВА КВОРУМА БАКТЕРИЙ

ТЕРАПЕВТИЧЕСКИЕ СЛИТЫЕ БЕЛКИ НАПРАВЛЕННОГО ДЕЙСТВИЯ НА ОСНОВЕ ЛИЗОСОМНЫХ ФЕРМЕНТОВ, СООТВЕТСТВУЮЩИЕ СОСТАВЫ И ИХ ПРИМЕНЕНИЯ

КОМПОЗИЦИИ НА ОСНОВЕ СИАЛИРОВАННЫХ ГЛИКОПРОТЕИНОВ И ИХ ПРИМЕНЕНИЕ

КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГЛЮКОЦЕРЕБРОЗИДАЗУ И ИЗОФАГОМИН

КАПСИДЫ ВАРИАНТОВ АДЕНОАССОЦИИРОВАННЫХ ВИРУСОВ И МЕТОДЫ ИХ ПРИМЕНЕНИЯ

НОВЫЕ ЛЕКАРСТВЕННЫЕ СРЕДСТВА ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ НА ОСНОВЕ СУЛЬФАТИРОВАННОЙ ГИАЛУРОНОВОЙ КИСЛОТЫ В КАЧЕСТВЕ СТИМУЛЯТОРОВ ИЛИ ИНГИБИТОРОВ ЦИТОКИНОВОЙ АКТИВНОСТИ

... 1. Сульфатированная гиалуроновая кислота для местного применения для профилактики и/или лечения воспалительных/вызывающих раздражение заболеваний кожи, выбранных из дерматита, атопического дерматита, фотодерматита, сыпи, витилиго, экземы, псориаза, всех раздражений кожи, связанных с активацией провоспалительных цитокинов, таких как IL-1, IL-2, IL-6, IL-7, IL-8, IL-12 и TNF, причем указанная сульфатированная гиалуроновая кислота (HA) имеет молекулярную массу в диапазоне от 10000 до 50000 Да, от 150000 до 250000 Да или от 500000 до 750000 Да и степень сульфатации, равную 1 или 3.2. Сульфатированная гиалуроновая кислота для местного применения в качестве гидратирующего агента для лечения патологических состояний кожи, характеризуемых сухостью, лихенификацией, раздражением, зудом и гиперемией, воспалением и шелушением, причем указанная сульфатированная гиалуроновая кислота (HA) имеет молекулярную массу в диапазоне от 10000 до 50000 Да, от 150000 до 250000 Да или от 500000 до 750000 Да и степень ...

ПЕРОРАЛЬНО ВВОДИМАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЛЕЧЕНИЯ СИНДРОМА РАЗДРАЖЕННОГО КИШЕЧНИКА, СОДЕРЖАЩАЯ РЕГУЛЯТОР ПЕРИСТАЛЬТИКИ КИШЕЧНИКА, СРЕДСТВО, КОТОРОЕ ПРЕДОТВРАЩАЕТ ЗАДЕРЖКУ ГАЗОВ, И ПИЩЕВАРИТЕЛЬНЫЕ ФЕРМЕНТЫ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ

... 1. Фармацевтическая композиция или состав, адаптированный для перорального введения, в форме таблетки, покрытой оболочкой таблетки или капсулы для предотвращения или лечения кишечных нарушений, где состав состоит из регулятора перистальтики кишечника, средства, которое предотвращает задержку газов, пищеварительного фермента, связующего средства, разбавителя, абсорбирующего средства, дезинтегрирующего средства, смазывающего средства и средства, способствующего скольжению.2. Фармацевтический состав по п. 1, где регулятор перистальтики кишечника выбран из группы, которая состоит из тримебутина, феноверина, мебеверина, дицикловерина, этилбромида, алосетрона, тегасерода, лоперамида, флороглюцинола, триметилфлороглюцинола, бутилскополамина и паргеверина.3. Фармацевтический состав по п.2, где регулятор перистальтики кишечника представляет собой тримебутин и его фармацевтически приемлемые соли.4. Фармацевтический состав по п.2, где регулятор перистальтики кишечника представляет собой феноверин ...

ПРЕДОТВРАЩЕНИЕ, РАЗРУШЕНИЕ И ОБРАБОТКА БИОПЛЕНКИ ЛИЗИНОМ БАКТЕРИОФАГА

СПОСОБ ЛЕЧЕНИЯ ХРОНИЧЕСКОГО ЭНДОМЕТРИТА

БАКТЕРИОФАГИ, ФАГОВЫЕ ПЕПТИДЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ

КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ ЛЕЧЕНИЯ БОЛЕЗНИ ГОШЕ

... 1. Способ лечения субъекта с болезнью Гоше, включающий проведение глюкоцереброзидазной заместительной ферментной терапии путем внутривенных инфузий субъекту в течение периода времени менее 2 ч в лечебных целях.2. Способ согласно п.1, отличающийся тем, что введение глюкоцереброзидазной заместительной ферментной терапии осуществляют в течение 90 мин или менее.3. Способ согласно п.1, отличающийся тем, что введение глюкоцереброзидазной заместительной ферментной терапии осуществляют в течение 60 мин или менее.4. Способ согласно п.1, отличающийся тем, что дополнительно содержит введение второго препарата для глюкоцереброзидазной заместительной ферментной терапии путем внутривенных инфузий субъекту в течение периода времени менее 2 ч.5. Способ согласно п.1, отличающийся тем, что препарат для глюкоцереброзидазной заместительной ферментной терапии выбирают из группы, состоящей из велаглюцеразы, имиглюцеразы и uplyso.6. Способ согласно п.1, отличающийся тем, что введение глюкоцереброзидазной заместительной ...

КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ ИНТЕРНАЛИЗАЦИИ ФЕРМЕНТОВ

ВЕКТОР НА ОСНОВЕ АДЕНОАССОЦИИРОВАННОГО ВИРУСА ДЛЯ ТЕРАПЕВТИЧЕСКОЙ ДОСТАВКИ В ЦЕНТРАЛЬНУЮ НЕРВНУЮ СИСТЕМУ

ПРИМЕНЕНИЕ ЛИЗИНА ДЛЯ ВОССТАНОВЛЕНИЯ/УВЕЛИЧЕНИЯ АНТИБАКТЕРИАЛЬНОЙ АКТИВНОСТИ АНТИБИОТИКОВ В ПРИСУТСТВИИ ЛЕГОЧНОГО СУРФАКТАНТА, КОТОРЫЙ ИНГИБИРУЕТ УКАЗАННЫЕ АНТИБИОТИКИ

НОВЫЕ МОДУЛЯТОРЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ

... 1. Антитело, включающее химерное, CDR-привитое, гуманизированное или рекомбинантное человеческое антитело или его фрагмент, которое(ый) специфически связывается с человеческим EFNA4 (эфрин А4) и которое(ый) конкурирует за связывание с человеческим EFNA4 с антителом, содержащим:а) вариабельную область тяжелой цепи, указанную как SEQ ID NO:113, и вариабельную область легкой цепи, указанную как SEQ ID NO:115;б) вариабельную область тяжелой цепи, указанную как SEQ ID NO:121, и вариабельную область легкой цепи, указанную как SEQ ID NO:123; илив) вариабельную область тяжелой цепи, указанную как SEQ ID NO:137, и вариабельную область легкой цепи, указанную как SEQ ID NO:139.2. Антитело по п.1, которое представляет собой нейтрализующее или истощающее антитело.3. Антитело по п.1, которое представляет собой интернализованное антитело.4. Антитело по п.1, содержащее по меньшей мере одну вариабельную область тяжелой цепи и по меньшей мере одну вариабельную область легкой цепи, где по меньшей мере одна ...

КОМБИНАЦИИ ЛИЗИНА БАКТЕРИОФАГА И АНТИБИОТИКА ПРОТИВ ГРАМ-ПОЛОЖИТЕЛЬНЫХ БАКТЕРИЙ

... 1. Способ лизиса грамположительных бактерий, включающий контактирование бактерий с комбинацией лизина PlySs2 и одного или нескольких антибиотиков, где количество PlySs2, требуемое для эффективного лизиса грамположительных бактерий, включая S. aureus, в присутствии антибиотика является значительно меньшим, чем в отсутствии антибиотика, и/или количество антибиотика, требуемое для эффективного лизиса грамположительных бактерий, включая S. aureus, в присутствии PlySs2 является значительно меньшим, чем в отсутствии PlySs2.2. Способ по п. 1, где количество антибиотика, требуемое для эффективного лизиса грамположительных бактерий, включая S. aureus, в присутствии PlySs2 является значительно меньшим, чем в отсутствии PlySs2.3. Способ по п. 1, где количество PlySs2, требуемое для эффективного лизиса грамположительных бактерий, включая S. aureus, в присутствии антибиотика является значительно меньшим, чем в отсутствии антибиотика.4. Способ по любому из пп. 1-3, где лизин PlySs2 содержит аминокислотную ...

НОВЫЕ ЛЕКАРСТВЕННЫЕ СРЕДСТВА ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ НА ОСНОВЕ СУЛЬФАТИРОВАННОЙ ГИАЛУРОНОВОЙ КИСЛОТЫ В КАЧЕСТВЕ СТИМУЛЯТОРОВ ИЛИ ИНГИБИТОРОВ ЦИТОКИНОВОЙ АКТИВНОСТИ

... 1. Сульфатированная гиалуроновая кислота для местного применения для профилактики и/или лечения простого герпеса губ и половых органов, вируса везикулярного стоматита и цитомегаловируса, причем указанная сульфатированная гиалуроновая кислота (HA) имеет молекулярную массу в диапазоне от 10000 до 50000 Да, от 150000 до 250000 Да или от 500000 до 750000 Да и степень сульфатации, равную 1 или 3.2. Фармацевтическая композиция для местного применения, содержащая сульфатированную гиалуроновую кислоту по п. 1, возможно, совместно с фармакологически и/или биологически активными средствами.3. Фармацевтическая композиция по п. 2, содержащая стероиды, гормоны, белки, трофические факторы, витамины, нестероидные противовоспалительные лекарственные средства, химиотерапевтические лекарственные средства для местного применения, антибиотики, противовирусные средства, местные анестетики, антикоагулянты и/или фибринолитические средства, ферменты и/или другие протеазы.4. Фармацевтическая композиция по п. 3, ...

Verwendung eines Enzyms zur Herstellung eines Mittels für die Behandlung und/oder Prophylaxe von Coccidiose

TONIKUM FUER DIE HUMANMEDIZIN UND TIERMEDIZIN UND VERFAHREN ZU SEINER HERSTELLUNG

Hydrogel comprising protein or enzyme bonded to PEG via urea groups, useful as a dressing for wounds and burns

A hydrogel formed from a protein and/or enzyme and/or SOD/catalase enzyme mimic bonded to a PEG via urea groups is new. The hydrogel consists of (A) at least one protein and/or enzyme and/or SOD/catalase enzyme mimic (including protein and enzyme fragments and/or recombinantly produced forms) bonded to (B) a PEG via urea groups. An Independent claim is also included for the preparation of the hydrogel.

POLYPEPTIDE ZUR AUSLÖSUNG EINER IMMUNREAKTION GEGEN KREBS

VERNETZTE, NICHT VON PILZEN KOMMENDE LIPASE ENTHALTENDE ZUSAMMENSETZUNG UND METHODEN ZU DEREN VERWENDUNG

ORALE PHARMAZEUTISCHE ZUSAMMENSETZUNGEN VON PRODUKTEN MIT LIPASE, INSBESONDERE VON PANKREATIN, MIT TENSIDEN

Therapeutic uses of a composition comprising an amylase, a lipase and a protease

Physiological enzyme comprising an amylase, a lipase and a protease for the treatment of excess polysaccharides and disaccharides associated with malfunctioning or absence amylase enzyme activity. The enzymes may be of human (saliva or pancreatic enzymes), yeast, plant, fungi, and or microbial origin, and preferably a digestive enzyme complex such as, 4-a-D-glucan glucanohydrolase; Exo-1,4-aglucosidase; Beta-fructofuranosidase; Protease (3.0); Pectinase; Lipase; Cellulase; Lactase; Malt Diastase, or digestive enzyme complex containing pancreatin,. The invention also relates to the production of pharmaceutical compositions suitable for such treatment. The disease condition exemplified is diabetes although others including asthma, kidney failure, wounds and ulcers, arthritis, deep vein thrombosis, embolism are also disclosed. A test strip that reacts with glucose in the blood comprising amylase or invertase enzymes or betaine HCL (trimethylglycine) is also claimed.

Feed additive composition

Acinetobacter lysins

Drug composition and its use in therapy

Exosomes comprising therapeutic polypeptides

Animal feed additive comprising enzyme and amino acid

A concentrated animal feed additive containing a plant tissue-destruction enzyme and at least one essential amino acid effective for increasing milk yield, improving milk qualities, promoting growth, improving the meat qualities and elevating the breeding efficiency of animals. The enzyme may comprise at least one of cellulase, xylanase, mannanase, laminarinase, pectinase, amylase, ligninase, protease and dextranase, and the amino acid selected from lysine, methionine, threonine and tryptophan.

Materials and methods for the treatment of cns damage

Acinetobacter lysins

Acinetobacter lysin polypeptides and variants peptides with killing activity against gram negative bacteria. Methods for treating bacterial infections or bacterial colonization using Acintobacter lysin polypeptides.

Products

Use of an enzyme for manufacturing an agent for controlling bacterial infection

Conditioning regimen for transplant of stem cells

Methods

Treatment

A method for improving athletic energy and/or endurance in a human subject

Method for improving athletic energy and/or endurance in a human comprising administering to a human a malt extract comprising active or denatured enzymes selected from amylases, maltases, cellulases, fructanases, glucanases, xylanases, and deacetylases. The extract may additionally comprise active or denatured proteinases and/or lipases, maltose, maltotriose, and maltose polymers. The malt may be extracted from the seeds of barely, wheat, triticale, sorghum, maize, buck wheat, or rice. The daily dose of malt extract is 0.0001-1.0 g per 1000 g human body weight. The diastatic power of the malt extract is above 35 degrees Lintner. Also disclosed is a denatured malt extract comprising enzymes selected from amylases, maltases, cellulases, fructanases, glucanases, xylanases, deacetylases, where all enzymes are denatured. The malt extract may additionally comprise denatured proteinases and/or lipases, maltose, maltotriose, and maltose polymers. The denatured malt extract may be extracted from ...

New applications of lysozyme dimer

New applications of lysozyme dimer.

The present invention relates to the use of a lysozyme dimer for the manufacture of a ...

New applicants of lysozyme dimer.

The present invention relates to the use of a lysozyme dimer for the manufacture of a pharmaceutical composition for the stimulation of non-specific cellular of humoral defense mechanisms of the immune system of a human or animal individual. The stimulation comprises increasing phagocytic activity and increasing at least one parameter selected from the group consisting of ceruioplasmin level, respiratory burst activity, immunoglobulin level, and lysozyme activity. The stimulation optionally further comprises regulating serum levels of free oxygen radicals. The pharmaceutical composition may be used for preventing or treating leukaemia, hair growth disorders, fish diseases and bee diseases.

New applications of lysozyme dimer

New applications of lysozyme dimer

Antiviral or antibacterial compound and method of use

Lysozyme dimer and compositions containing the same

Amylase-electrolyte oral rehydration method and apparatus

New applications of lysozyme dimer

New applications of lysozyme dimer

PROCEDURE FOR THE PRODUCTION OF MICRO CAPS

HYALURONIDASE COMPOSITIONS FOR TREATMENT INTRAVITREALEN OF HEMORRHAGI BLOOD

SOUR ALPHA GLUKOSIDASE ONES AND FRAGMENTS OF IT

USE OF SYNERGISTIC LYTI ENZYMES FROM BACTERIOPHAGES FOR THE PREVENTION AND TREATMENT OF BACTERIAL INFECTIONS

COMBINATION PREPARATIONS CONTAINING 2METHYLTHIAZOLIDIN-2,4-DICARBONSÄURE

ENZYMES FOR PHARMACEUTICAL APPLICATION

IN DER TIERZUCHT VERWENDETES PRÄPARAT SOWIE VERFAHREN ZU DESSEN HERSTELLUNG

VERFAHREN ZUR STIMULIERUNG DER IMMUNOLOGISCHEN REAKTIVITAET EINES ANTIGENS

TITER INCREASE FOR ANIMAL INOCULATION

ENZYME-CONTAINING PREPARATION, PROCEDURE FOR THE PRODUCTION AND USE

USE OF HSP70 AS AUTOMATIC CONTROLLERS OF THE ENZYMATIC ACTIVITY

POLYPEPTIDE FOR THE RELEASE OF AN IMMUNE REACTION AGAINST CANCER

PROCEDURE FOR THE PRODUCTION A HYALURONIDASE OF CONTAINING PREPARATION

TREATMENT OF THE POMPE ILLNESS

PROCEDURE FOR THE TREATMENT OF DISEASES OF HUMANS IN CONNECTION WITH A INCREASED ONE DESOXYRIBONUCLEINSÄUREGEHALT IN EXTRACELLULAR AREAS OF FABRICS AND MEDICAL PREPARATION FOR THE EXECUTION OF THE PROCEDURE

KATABOLI ENZYMES FOR THE INDUCTION OF THE TUMOR NECROSIS FACTOR (TNF).

USE OF ALPHA D GALACTOSIDASE SUGARS BOUND FOR THE PRODUCTION OF A PHARMACEUTICAL COMPOSITION TO THE ALLEVIATION OF GASTRO INTESTINALEN COMPLAINTS THROUGH ALPHA D GALACTOSID.

USE A LYSOZYMDIMEREN AND/OR RIBONUCLEASEDIMEREN FOR THE PRODUCTION OF AN ANTIVIRAL OR ANTIBACTERIAL DRUG.

ARTIFICIAL SALIVA COMPOSITIONS

PROCEDURE FOR THE SKIN CARE AND MEANS

PHARMACEUTICAL COMPOSITION FROM SPIDER POISONS AS WELL AS THEIR PRODUCTION AND USE FOR THE TREATMENT OF TUMOR ILLNESSES

Adverse side-effects associated with administration of anti-hyaluronan agents and methods for ameliorating or preventing the side-effects

Provided herein are methods for ameliorating an adverse effect of systemic administration of a PEG hyaluronan degrading enzyme to a subject. The methods involve systemically administering a PEGylated hyaluronan degrading enzyme, particularly a PEGylated hyaluronidase, such as any of the animal or bacterial hyaluronidases, to the subject and administering an amount of a corticosteroid sufficient to ameliorate the adverse effect. Also provided are method of treating a hyaluronan-associated disease or condition for single-agent therapy or combination therapy.

Methods and materials for delivering molecules

This document relates to methods and materials involved in delivering molecules to a mammal. For example, methods and materials for using nanoparticles to increase the half-life and the bioavailability of molecules administered to a mammal are provided.

Oral composition and method of forming and using same

An oral composition for the treatment of dry mouth symptoms and other conditions, a method of forming the oral composition, and a method of using the oral composition are disclosed. The oral composition includes a plurality of enzymes to prevent formation of and/or facilitate the break up of biofilm in an oral cavity and a metal ion management system to inhibit growth of gram negative bacteria.

Extracellular yaluronidase from streptomyces koganeiensis

The invention relates to Streptomyces koganeiensis ATCC 31394 hyaluronidase having molecular weight of 21.6 kDalton, which has hyaluronidase activity and stability markedly higher than those of the hyaluronidase obtained from such microorganism to date. The invention further relates to a process for the isolation and purification of said hyaluronidase and its use for the preparation of pharmaceutical compositions or as an analytical reagent.

Pharmaceutical preparation for the treatment of the symptoms of addiction and method of diagnosing same

A therapeutic agent for the treatment of the symptoms of addiction and the method for preparing the therapeutic agent is disclosed. The therapeutic agent is a stable pharmaceutical preparation containing, but not limited to, digestive/pancreatic enzymes. The therapeutic agent may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic agent may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using of a biomarker, the presence of chymotrypsin in the gastrointestinal tract to determine the presence of symptoms of addiction, and the likelihood of relapsing into addiction is disclosed.

Klotho protein and related compounds for the treatment and diagnosis of cancer

Disclosed is the use of a klotho protein or related compounds (especially KL1 or KL1 analogue) for treatment, and especially treatment of cancer, alone or together with other active pharmaceutical ingredients such as chemotherapeutic agents.

Enzyme Delivery Systems and Methods of Preparation and Use

This invention relates to coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations. This invention further relates to methods of preparation and use of the systems, pharmaceutical compositions and preparations to treat persons having ADD, ADHD, autism, cystic fibrosis and other behavioral and neurological disorders.

Tetranectin-apolipoprotein a-i, lipid particles containing it and its use

A lipid particle comprising an apolipoprotein, a phosphatidylcholine and a lipid, such as a phospholipid, fatty acid or steroid lipid. In one embodiment the lipid particle comprises only one apolipoprotein. In one embodiment the lipid particle is consisting of one apolipoprotein, a phospholipid, a lipid, and a detergent. In one embodiment the lipid is a second phosphatidylcholine, wherein the first phosphatidylcholine and the second phosphatidylcholine differ in one or two fatty acid residues or fatty acid residue derivatives which are esterified to the glycerol backbone of the phosphatidylcholine. In one embodiment the apolipoprotein is selected from an apolipoprotein that has the amino acid sequence selected from SEQ ID NO: 01, 02, 06, 66, and 67, or is a variant thereof that has at least 70% sequence identity with the selected sequence.

Spray dried myrosinase and use to produce isothiocynates

A spray dried myrosinase/ascorbate mixture is formed from the steps comprising: providing a source of myrosinase, adding ascorbate to the source of myrosinase, heating the source of myrosinase to a temperature of about 104° F. (about 40° C.) or higher, and spray drying the myrosinase/ascorbate mixture. The spray dried myrosinase/ascorbate mixture may be used to prepare isothiocyanates. The spray dried myrosinase/ascorbate mixture may also be mixed with glucoraphanin and used in an activated tablet or capsule.

Super fast-acting insulin compositions

Provided are methods for control of post-prandial glucose in diabetic subjects by administering a fast-acting insulin analog and a hyaluronidase degrading enzyme. The fast-acting insulin analog and a hyaluronidase are administered between 15 minutes before the meal and 30 minutes after commencing the meal.

Chimeric bacteriophage lysin with activity against staphylococci bacteria

The present disclosure relates to chimeric bacteriophage lysins useful for the identification and/or reduction of staphylococcal populations. For example, a chimeric bacteriophage lysin was engineered and shown to effectively kill all strains of staphylococci tested including antibiotic resistant methicillin-resistant S. Aureus and VISA.

Egg White Antibodies for Prevention and Treatment of Specific Localized Intestinal Infections and Diseases Associated with a Pathogenic Organism or Molecule

The present invention provides the method for prevention and treatment of specific localized intestinal infections and diseases using IgA and IgM antibodies obtained from the eggs of hens which have been hyperimmunized to the same specific infections and diseases. The invention describes the high functionality of IgA and IgM antibodies present in the white of an egg from a hyperimmunized chicken as compared to the IgY from the same egg. The invention also describes the resistance of IgA and IgM to low pH environments such as stomach acids. The invention also describes the inhibition of bacterial growth when bacteria are exposed to IgA antibodies specific to said bacteria together with lysozyme from egg whites.

Compositions and methods for reducing the incidence of equine digestive disorders

The present invention encompasses compositions and methods of reducing the incidence of equine digestive disorders.

Treatment of Pompe's Disease

The invention provides methods of treating Pompe's disease using human acid alpha glucosidase. A preferred treatment regime comprises administering greater than 10 mg/kg body weight per week to a patient.

Transplantable graft-specific induced tolerogenic dendritic cells and methods of use

Disclosed are transplantable graft-specific induced tolerogenic dendritic cells (itDCs), as well as related compositions and methods.

Induced tolerogenic dendritic cells to reduce systemic inflammatory cytokines

Disclosed are induced tolerogenic dendritic cells (itDCs), as well as related compositions and methods, for reducing systemic inflammatory cytokines.

Compositions and combinations of organophosphorus bioscavengers and hyaluronan-degrading enzymes, and methods of use

Provided are compositions and combinations containing an organophosphorus bioscavenger and a hyaluronan-degrading enzyme. The provided compositions and combinations can be used to treat or prevent organophosphorus poisoning, including nerve agent poisoning and pesticide poisoning. 1. A composition , comprising an organophosphorus (OP) bioscavenger and a hyaluronan-degrading enzyme.2. The composition of that is formulated for single dosage administration.3. The composition of claim 1 , wherein the organophosphorus bioscavenger is an esterase claim 1 , cholinesterase claim 1 , paraoxonase claim 1 , aryldialkylphosphatase or diisopropylfluorophosphatase.4. The composition of claim 1 , wherein the organophosphorus bioscavenger is selected from among acetylcholinesterase (AChE) claim 1 , butyrylcholinesterase (BChE) claim 1 , prolidase claim 1 , organophosphate acid anhydrolase (OPAA) claim 1 , phosphotriesterase claim 1 , aryldialkylphosphatase claim 1 , organophosphorus hydrolase (OPH) claim 1 , parathion hydrolase claim 1 , diisopropylfluorophosphatase (DFPase) claim 1 , organophosphorus acid anhydrase claim 1 , sarinase and paraoxonase (PON) and an active portion thereof or a variant thereof that exhibits at least 80% OP binding or inactivating activity.5. The composition of claim 1 , wherein the organophosphorus bioscavenger has the sequence of amino acids set forth in any of SEQ ID NOS: 214-256 and 258-301 claim 1 , an active portion thereof or a variant thereof that exhibits at least 80% sequence identity to any of SEQ ID NOS: 214-256 and 258-301.6. The composition of claim 1 , wherein the organophosphorus bioscavenger is butyrylcholinesterase that has the sequence of amino acids set forth in SEQ ID NO:236 claim 1 , or is an active portion thereof or is a variant thereof that exhibits at least 85% sequence identity to the sequence of amino acids set forth in SEQ ID NO:236.7. The composition of claim 1 , wherein the organophosphorus bioscavenger is modified with a ...

METHODS FOR THE TREATMENT OF TAY-SACHS DISEASE, SANDHOFF DISEASE, AND GM1-GANGLIOSIDOSIS

The present disclosure provides methods for the treatment of lysosomal storage disorders using gene replacement therapy. In particular, methods are provided for the treatment of Tay-Sachs disease, Sandhoff Disease, and GM1-gangliosidosis using enzyme replacement therapy. Expression constructs encoding enzymes required for ganglioside metabolism are delivered to the brain of subjects with an enzyme deficiency. Methods are also provided for delaying the onset of, reducing the likelihood of onset of, or reducing the severity of Tay-Sachs disease, Sandhoff Disease, and GM1-gangliosidosis. 1. A method for enhancing β-N-acetylhexosaminidase activity in a subject in need thereof , comprising: (i) the first construct expresses the β-N-acetylhexosaminidase β subunit; and', '(ii) the second construct expresses the β-N-acetylhexosaminidase α subunit;, 'administering to the subject a therapeutically effective amount of a composition comprising a first expression construct and a second expression construct, wherein'}wherein the composition is administered to at least two or more brain areas of the subject, the brain areas selected from the group consisting of thalamus, striatum, deep cerebellar nuclei, and ventral tegmental area.2. The method of claim 1 , wherein the subject is a human predisposed to having claim 1 , suspected of having claim 1 , or diagnosed as having a β-N-acetylhexosaminidase deficiency.3. The method of claim 2 , wherein the β-N-acetylhexosaminidase deficiency comprises a lysosomal storage disorder.4. The method of claim 2 , wherein the β-N-acetylhexosaminidase deficiency comprises Tay-Sachs Disease or Sandhoff Disease.5. The method of claim 2 , wherein the β-N-acetylhexosaminidase deficiency comprises a partial or complete loss of endogenous expression or function of the β-N-acetylhexosaminidase subunit claim 2 , β subunit claim 2 , α subunit claim 2 , or both.6. The method of claim 1 , wherein the expression constructs comprise the adeno-associated virus ( ...

RECOMBINANT HUMAN NAGLU PROTEIN AND USES THEREOF

The present invention provides compositions comprising an isolated mixture of recombinant human NaGlu proteins in which a substantial amount of the NaGlu proteins in the mixture has increased levels of phosphorylated mannose that confer the proteins to be efficiently internalized into human cells. The present invention also provides methods of producing such mixture of NaGlu proteins, vectors used in transgenesis and expression, host cells harboring such vectors, and methods of isolating and purifying the mixture of NaGlu proteins. The invention further provides methods of treating NaGlu associated diseases. 1. A composition comprising an isolated mixture of recombinant human N-acetyl-alpha-D-glucosaminidase (rhNaGlu) comprising the amino acid sequence 24-743 of SEQ ID NO:1 , wherein at least 10% of said rhNaGlu in said mixture comprises at least one glycan structure having mannose-6-phosphate (M6P).2. The composition of claim 1 , wherein said rhNaGlu having M6P is capable of being taken up into a mammalian cell deficient in NaGlu such that internalized rhNaGlu restores at least 50% of normal NaGlu activity observed in a wild-type mammalian cell of the same type.3. The composition of claim 2 , wherein said rhNaGlu contains at least 1 mole of M6P per mole of protein.4. The composition of claim 3 , wherein said rhNaGlu contains about 3 moles of M6P per mole of protein.5. The composition of claim 2 , wherein said mammalian cell deficient in NaGlu is a human cell.6. The composition of claim 2 , wherein said rhNaGlu is effectively delivered to the brain of a mammal having NaGlu deficiency when systemically administered.7. The composition of claim 6 , wherein said rhNaGlu is effectively delivered to the brain of a mammal having NaGlu deficiency when intravenously administered.8. The composition of claim 2 , wherein said rhNaGlu is effectively delivered to the brain of a mammal having NaGlu deficiency when administered intrathecally.9. The composition of claim 2 , wherein ...

TEMPERATURE-SENSITIVE CARRIER FOR CARRYING A PHYSIOLOGICALLY ACTIVE SUBSTANCE AND PREPARATION METHOD THEREOF

The present invention relates to a temperature-sensitive carrier for carrying a physiologically active substance and a preparation method thereof. Specifically, the temperature-sensitive carrier according to the present invention comprises an amphiphilic biodegradable block copolymer containing polysaccharide or polysaccharide and succinic anhydride as a hydrophilic block and polylactide as a non-ionic block. A hydrophilic polymer-polylactide copolymer according to the present invention forms a stable complex with a physiologically active substance such as protein, polynucleotide and the like in vivo via ionic bonding and temperature-sensitive hydrophobic bonding. Therefore, a copolymer according to the present invention can facilitate in vivo delivery of a physiologically active substance and used as an in vivo drug delivery system. 1. A temperature-sensitive carrier for carrying a physiologically active substance , which comprises a copolymer of (i) a combination of a polysaccharide and succinic anhydride and (ii) polylactide.2. The temperature-sensitive carrier according to claim 1 , wherein said polysaccharide is inherently charged and comprises a non-toxic unit having a molecular weight of at least 5 claim 1 ,000.3. The temperature-sensitive carrier according to claim 2 , wherein said polysaccharide is a hydrophilic pullulan or hyaluronic acid derivative.4. The temperature-sensitive carrier according to claim 1 , wherein (i) a combination of a polysaccharide and succinic anhydride and (ii) polylactide are combined in the weight ratio of 1:0.5 to 1:5.5. The temperature-sensitive carrier according to claim 1 , wherein said carrier is combined with at least one physiologically active substance selected from the group consisting of protein claim 1 , peptide claim 1 , nucleotide and small organic compounds having a hydrophobic or hydrophilic functional group.6. The temperature-sensitive carrier according to claim 5 , wherein said physiologically active substance is ...

COMPOSITIONS AND METHODS FOR REDUCING MICROBIAL OVERGROWTH IN THE SMALL INTESTINES

An antimicrobial composition for reducing bacterial overgrowth in the small intestine is disclosed. The composition comprises a lytic enzyme combined with one or more anti-microbial essential oils, and a probiotic. Unlike broad spectrum antibiotics the disclosed composition does not enter the blood stream, does not destroy all intestinal microflora, and can be used on a continuing basis. 1. An antimicrobial composition , comprising:(a) one or more lytic enzymes;(b) one or more antimicrobial essential oils; and(c) a probiotic.2. The antimicrobial composition of claim 1 , wherein the one or more lytic enzymes are selected from the group consisting of lysozyme claim 1 , lysostaphin claim 1 , zymolase claim 1 , cellulase claim 1 , mutanolysin claim 1 , glycanases claim 1 , proteases claim 1 , mannase claim 1 , and lactoperoxidase.3. The antimicrobial composition of claim 2 , wherein the one or more lytic enzymes comprise egg lysozyme.4. The antimicrobial composition of claim 1 , comprising about 10 mg to about 1000 mg of the one or more lytic enzymes per unit dose.5. The antimicrobial composition of claim 4 , comprising about 75 mg to about 150 mg of the one or more lytic enzymes per unit dose.6. The antimicrobial composition of claim 1 , wherein the one or more antimicrobial essential oils are selected from the group consisting of carvarcol claim 1 , thymol claim 1 , oils of ginger claim 1 , cinnamon claim 1 , mint claim 1 , onion claim 1 , black cumin claim 1 , oregano claim 1 , thyme claim 1 , clove claim 1 , garlic claim 1 , eucalyptus claim 1 , lavender claim 1 , leleshwa claim 1 , lemon claim 1 , lemon myrtle claim 1 , neem claim 1 , cilantro claim 1 , tea tree and peppermint.7. The antimicrobial composition of claim 6 , wherein the one or more antimicrobial essential oils comprise oils of garlic claim 6 , oregano claim 6 , thyme claim 6 , or any combination thereof.8. The antimicrobial composition of claim 1 , wherein the composition comprises about 5 mg to about ...

Enzyme and Prebiotic Combinations for Enhancing Probiotic Efficacy

This disclosure relates to enhancing growth and/or activity of lactobacilli using a prebiotic formulation which includes iso-malto oligosaccharides and α-galactosidase; and to enhancing growth and/or activity of bifidobacteria using a prebiotic formulation which includes iso-malto oligosaccharides and β-glucanase. Other combinations of fibers and enzymes are described below which also stimulate growth and activity of lactobacilli or bifidobacteria. These combinations of enzymes and prebiotics can be taken separately or added to foods, including desserts. 1lactobacillus. A formulation for enhancing growth or activity in vivo comprising α-galactosidase and isomalto-oligosaccharide.2the lactobacillusLactobacillus acidophilus, Lactobacillus salivarius, Lactobacillus paracasei, Lactobacillus plantarumLactobacillus rhamnosus.. The formulation of wherein species is or3. The formulation of further including sunflower lecithin or oleic acid.4. The formulation of further including polysorbate 80.5. The formulation of further including pectinase.6. The formulation of further including β-glucanase.7. The formulation of further including milk products including yogurt.8bifidobacterium. A formulation for enhancing growth or activity in vivo comprising β-glucanase and isomalto-oligosaccharide.9bifidobacteriumBifidobacterium lactisBifidobacterium breve.. The formulation of wherein the species is (strain BL-04 or Bi-07) or10. The formulation of further including sunflower lecithin or oleic acid.11. The formulation of further including polysorbate 80.12. The formulation of further including α-galactosidase.13. The formulation of further including pectinase.14. The formulation of further including milk products including yogurt.15lactobacillusbifidobacterium. A formulation for enhancing and growth or activity in vivo comprising α-galactosidase claim 8 , β-glucanase and isomalto-oligosaccharide.16lactobacillusLactobacillus acidophilus, Lactobacillus salivarius, Lactobacillus paracasei, ...

Botulinum toxin compositions and methods

Disclosed herein are methods of using extracellular matrix digesting enzymes and neurotoxins, such as a Clostridial neurotoxins, to treat various medical conditions, such as overactive bladder, benign prostatic hyperplasia, hyperhidrosis, for example.

COMPOSITIONS AND METHODS FOR TARGETING AND TREATING DISEASES AND INJURIES USING ADENO-ASSOCIATED VIRUS VECTORS

The present application discloses compositions and methods useful for targeting and treating injured or diseased muscle, including cardiac and skeletal muscle. Disclosed herein are adenoviral vectors modified to contain enhancers, promoters, and genes to target muscle with high efficiency and to induce tissue specific gene expression of transgenes. 1. A method of preventing or treating an injury , disease , or disorder in cardiac or skeletal muscle , said method comprising administering to a subject in need thereof a pharmaceutical composition comprising an effective amount of a recombinant adeno-associated viral (AAV) vector comprising a regulatory element active in muscle cells , wherein said regulatory element comprises at least one promoter element and optionally at least one enhancer element , further wherein said AAV vector comprises at least one gene operably linked to said at least one promoter , or active fragments , modifications , or homologs thereof , thereby preventing or treating an injury , disease , or disorder in cardiac or skeletal muscle.2. The method of claim 1 , wherein at least one promoter element is a tissue specific promoter.3. The method of claim 1 , wherein the AAV is AAVS (SEQ ID NO:11) or AAV9 (SEQ ID NOT).4. The method of claim 1 , wherein the at least one promoter element and the at least one enhancer element are from the same species of animal.5. The method of claim 4 , wherein the species is selected from group consisting of mouse claim 4 , human claim 4 , chicken claim 4 , and rat.6. The method of wherein the vector is AcTnTEcSOD.7. The method of claim 1 , wherein the at least one promoter is selected from the group consisting of a cardiac troponin-T promoter claim 1 , a muscle creatine kinase promoter claim 1 , and a desmin promoter.8. The method of claim 1 , wherein an effective amount of neuraminidase or other desialylation agent is administered to said subject before administration of said AAV vector.9. The method of claim 1 , ...

Methods, Compounds, and Compositions For Treatment and Prophylaxis in the Respiratory Tract

The present invention provides a method of reducing the quanitity of mucus in the respiratory tract of a subject with elevated levels of mucus in said respiratory tract. The method includes administering to the subject a compound or composition containing a therapeutically effective amount of a fusion protein comprising a sialidase or an active portion thereof and an anchoring domain. The therapeutically effective amount comprises an amount of the fusion protein that results in a reduction of the quanitity of mucus in the respiratory tract after administration of the compound or composition when compared to the quantity of mucus present prior to administration of the compound or composition.

Compositions and Methods for Using Human YKL-40 to Treat Acute Lung Injury

The invention includes methods of treating oxidant-mediated acute lung injury in a subject by administration of a chitinase-like protein molecule, or an activator thereof. The invention also includes methods of assessing the level of a chitinase-like protein molecule in a subject as a marker of the prognosis of a subject suffering from acute lung injury. 1. A method of treating acute lung injury in a subject , said method comprising administering an effective amount of a chitinase-like protein molecule , or activator thereof , to said subject , thereby treating said acute lung injury.2. The method of claim 1 , wherein said chitinase-like protein molecule is YKL-40.3. The method of claim 1 , wherein said acute lung injury is oxidant-mediated acute lung injury.4. The method of claim 1 , wherein said subject is a human.5. A method of preventing acute lung injury in a subject claim 1 , said method comprising administering an effective amount of a chitinase-like protein molecule claim 1 , or activator thereof claim 1 , to said subject claim 1 , thereby preventing said acute lung injury.6. The method of claim 5 , wherein said chitinase-like protein molecule is YKL0-40.7. The method of claim 5 , wherein said acute lung injury is oxidant-mediated acute lung injury.8. The method of claim 5 , wherein said subject is a human.9. A method of determining the severity of acute lung injury in a subject claim 5 , the method comprising:a. obtaining a sample from the subject, wherein the subject has, or is suspected of having, acute lung injury,b. determining in the sample the level of at least one chitinase-like protein molecule,c. comparing the level of the at least one chitinase-like protein molecule in the sample with the level in a control or reference standard, wherein the difference in the level of the at least one chitinase-like protein molecule between the sample and the control or reference standard is a measure of the severity of acute lung injury in the subject.10. The ...

COMPOSITIONS AND METHODS FOR TREATING CANCER AND MODULATING STRESS GRANULE FORMATION

The invention provides methods for treating or decreasing the likelihood of developing a stress-granule related disorder and/or cancer by administering one or more poly-ADP-ribose polymerase (PARP) inhibitors, one or more PARP activators, one or more poly-ADP-ribose glycosylase (PARG) activators, and/or one or more poly-ADP-ribose glycohydrolase ARH3 activators. The invention also provides corresponding methods of decreasing stress granule formation and/or proliferation in a cell or a population of cells. The invention further provides methods of increasing the number of stress granules and proliferation in a cell or a population of cells by administering one or more PARP activators, one or more PARP inhibitors, one or more PARG inhibitors, and/or one or more ARH3 inhibitors. The invention also provides methods for screening for agents for treating or decreasing the likelihood of developing a stress granule-related disorder or cancer, and methods for determining the propensity for developing a stress granule-related disorder or cancer, as well as compositions and kits containing one or more PARP inhibitors, one or more PARP activators, one or more PARG activators, and one or more ARH3 activators. 1. A method of treating or decreasing the likelihood of developing a stress granule-related disorder in a subject comprising administering to said subject a therapeutically effective amount of one or more poly-ADP-ribose polymerase (PARP) inhibitor(s) , one or more poly-ADP ribose glycolase (PARG) activators , and/or one or more PARP11 activators.2. The method of claim 1 , wherein said one or more PARP inhibitor(s) selectively decrease the expression and/or one or more activities of one or more PARP(s) selected from the group consisting of PARP5a claim 1 , PARP12 claim 1 , PARP13 isoform 1 (PARP13.1) claim 1 , PARP13 isoform 2 (PARP13.2) claim 1 , and PARP15.3. The method of claim 2 , wherein:(a) said decrease in expression is a decrease in the level of one or more nucleic ...

METHOD FOR TREATING ACIDOSIS IN RUMINANTS

The present invention provides a method for treating acidosis in a ruminant. The method includes administering an effective amount of a naturally derived inhibitor of a carbohydrate degrading enzyme to the ruminant. Such enzymes include amylase and glucosidase. In addition, the carbohydrate degrading enzyme may be endogenous or exogenous to the ruminant. 1. A method for treating acidosis in a ruminant in need thereof comprising administering an effective amount of a naturally derived inhibitor of a carbohydrate degrading enzyme to the ruminant.2. The method according to wherein the inhibitor of a carbohydrate degrading enzyme is derived from a bean.3. The method according to wherein the bean is Phaseolus vulgaris.4. The method according to wherein the carbohydrate-degrading enzyme is endogenous.5. The method according to wherein the enzyme is a pancreatic enzyme.6. The method according to wherein the enzyme is amylase.7. The method according to wherein the enzyme is glucosidase.8. The method according to wherein the carbohydrate degrading enzyme is exogenous.9. The method according to wherein the enzyme is produced by bacteria.10. The method according to wherein the bacteria are carbohydrate-fermenting bacteria in a forestomach of the ruminant.11. The method according to wherein the enzyme is amylase.12. The method according to wherein the enzyme is glucosidase.13. The method according to wherein the acidosis is chronic rumen acidosis.14. The method according to wherein the acidosis is acute rumen acidosis.15. The method according to wherein the acidosis is subacute rumen acidosis.16. The method according to wherein the acidosis is forestomach acidosis.17. The method of wherein the forestomach acidosis is acidosis of the rumen claim 16 , reticulum claim 16 , or omasum of the ruminant.18. The method according to wherein the administration comprises a feed paste claim 1 , pill claim 1 , gel claim 1 , gel cap claim 1 , or tablet.19. The method according to wherein the ...

AGENT FOR DYSFUNCTION DUE TO NEUROPATHY AND Rho KINASE ACTIVATION INHIBITOR

An object of the present invention is to provide a substance which is able to be an active ingredient for the improvement of dysfunction caused by nerve damage. An improving agent for dysfunction due to nerve damage of the present invention as a means for resolution thereof is characterized in that it comprises an endo-β-N-acetylglucosaminidase type enzyme which hydrolyzes an N-acetylglucosamide bond in a keratan sulfate backbone as an active ingredient. When the improving agent of the present invention is administered, clinical improvement is achieved in motor neuron dysfunction and sensory neuron dysfunction such as neuropathic pain represented by a pain caused by allodynia and hyperalgesic reaction of the object to be treated. 110-. (canceled)11. A method for improving neuropathic pain , comprising administering keratanase II as an endo-β-N-acetylglucosaminidase type enzyme which hydrolyzes an N-acetylglucosaminide bond in a keratan sulfate backbone to a patient suffering from neuropathic pain.12. The method according to claim 11 , wherein said keratanase II is a heat-resistant keratanase II having an excellent stability against heat where the optimum reaction temperature is 50 to 60° C.13. The method according to claim 11 , wherein said keratanase II is administered continuously to a neuropathic site.14. The method according to claim 13 , wherein said keratanase II is administered at the dose of 0.3 milliunit (mU) to 15000 mU per day to an adult human.15. The method according to claim 11 , wherein the neuropathic pain is that arising from spinal cord injury.16. The method according to claim 11 , wherein the neuropathic pain is a pain caused by allodynia or hyperalgesic reaction. The present invention relates to an improving agent for dysfunction due to nerve damage and to an Rho kinase activation inhibitor.In human central nervous system (CNS), it is very difficult to regenerate the neuronal axon which was once injured due to spinal cord injury, cerebrovascular ...

FORMULATIONS FOR TREATMENT WITH GLUCOSINOLATES

The application relates to topical formulations comprising a phase II enzyme inducer precursor and an activating agent. Methods for producing and using the topical formulations are also provided. 1. A formulation comprising:(a) at least one phase II enzyme inducer precursor and(b) at least one activating agent,wherein contact between said precursor and agent is substantially reduced during storage and the formulation is selected from the group consisting of a topical formulation, a pill, a beverage, and a food.2. The topical formulation of claim 1 , wherein said precursor is a glucosinolate.3. The topical formulation of claim 1 , wherein said agent is a myrosinase.4. The topical formulation of claim 1 , wherein said inducer is an isothiocyanate.5. The topical formulation of claim 1 , wherein said precursor and agent are each encapsulated.6. The topical formulation of claim 5 , wherein said precursor and agent are encapsulated in a carrier selected from the group comprising a micelle claim 5 , a liposome claim 5 , and a microsphere.7. The topical formulation of claim 5 , wherein said precursor and agent are encapsulated separately.8. The topical formulation of claim 5 , wherein said precursor and agent are separated by a thin layer.9. The topical formulation of claim 1 , wherein said precursor and agent are not encapsulated.10. The topical formulation of claim 9 , wherein said precursor and agent are placed in separate chambers in a container.11. The topical formulation of claim 9 , wherein said precursor and agent are placed in a thixotropic medium.12. The topical formulation of claim 1 , wherein the formulation is selected from the group consisting of a cream claim 1 , a lotion claim 1 , a gel claim 1 , an ointment claim 1 , a paste claim 1 , and an aerosol spray.13. The topical formulation of claim 1 , wherein the formulation is sterile at least prior to a first use of the formulation.14. The topical formulation of claim 1 , further comprising an antimicrobial ...

Maturation of gastrointestinal tract

The present invention provides a method to induce maturation of an immature GI-tract, such as intestine, e.g. small intestine, the method comprising the steps of administering a mixture of enzymes to the immature GI-tract, said enzymes having a pancreatic activity or action, and/or pancreatic like activity or action, and analysing the maturation process of the GI-tract to monitor said maturation process. Provided herein are also uses and kits to provide for GI-tract maturation.

Treatment of Synucleinopathies

This invention relates generally to treating synucleinopathies in subjects that are not clinically diagnosed with a lysosomal storage disease, as well as associated methods of making medicaments and screening methods. 1. A method of treating a subject with a synucleinopathy , but not a clinically diagnosed lysosomal storage disease , the method comprising administering to a subject any one or more of:an acid-beta-glucocerebrosidase (GBA) polypeptide,a polynucleotide encoding an acid-beta-glucocerebrosidase (GBA) polypeptide,a GBA polypeptide activating polypeptide,a polynucleotide encoding a GBA polypeptide activating agent,a cathepsin D polypeptide,a procathepsin D polypeptide, anda polynucleotide encoding a cathepsin D or procathepsin D polypeptide, in an amount effective to reduce a level of α-synuclein in the subject's central or peripheral nervous system, or both, or in the subject's lysosomal compartment.2. The method of claim 1 , wherein the synucleinopathy is a primary synucleinopathy.3. The method of claim 2 , wherein the synucleinopathy comprises any one or more of: Parkinson's disease (PD); sporadic or heritable dementia with Lewy bodies (DLB); pure autonomic failure (PAF) with α-synuclein deposition; multiple system atrophy (MSA); hereditary neurodegeneration with brain iron accumulation; and incidental Lewy body disease of advanced age.4. The method of claim 1 , wherein the synucleinopathy is a secondary synucleinopathy.5. The method of claim 4 , wherein the synucleinopathy comprises any one or more of: Alzheimer's disease of the Lewy body variant; Down's syndrome; progressive supranuclear palsy; essential tremor with Lewy bodies; familial parkinsonism with or without dementia; tau gene and progranulin gene-linked dementia with or without parkinsonism; Creutzfeldt Jakob disease; bovine spongiform encephalopathy; secondary Parkinson disease; parkinsonism resulting from neurotoxin exposure; drug-induced parkinsonism with α-synuclein deposition; sporadic ...

Hyaluronidase and Method of use Thereof

The present invention provides a tnaluronidase. The hyaiuronidase can be produced by the strain 77. Exemplary characteristics of the hyaluronidase include specific C-terminal or other amino acid sequences, including full-length sequences, and improved physico-chemical and actix itj properties as compared to known h>alνronidase preparatkiiis. Described are also various uses of the hyaiuronidase, including topical administration of the h>aiuronidase to improve skin penetration of a co-administered active substance. 19-. (canceled)10. A method of preventing or reducing scar formation comprising topical administration of a pharmaceutical formulation comprising an isolated hyaluronidase protein comprising an amino acid sequence as set forth in SEQ ID NO:1 , SEQ ID NO:2 or SEQ ID NO:4. and a pharmaceutically acceptable excipient , carrier , diluent , or auxiliary agent to a healing wound in a patient.11. (canceled)12. The method of claim 10 , wherein the wound was caused by burns.13. (canceled)14. A method of preventing or reducing formation of wrinkles comprising topical administration of a pharmaceutical formulation comprising an isolated hyaluronidase protein comprising an amino acid sequence as set fbrth in SEQ ID NO:1 claim 10 , SEQ ID NO:2 or SEQ ID NO:4. and a pharmaceutically acceptable excipient claim 10 , carrier claim 10 , diluent claim 10 , or auxiliary agent t to a skin area susceptible to wrinkle formation in a subject.1516-. (canceled)17. The method of claim 10 , wherein the scar is a keloid scar.1822-. (canceled)22. A method of improving the tissue penetration of a drug comprising administering the drug together with a pharmaceutical formulation comprising an isolated hyaluronidase protein comprising an amino acid sequence as set forth in SEQ ID NO:1 claim 10 , SEQ ID NO:2 or SEQ ID NO:4. and a pharmaceutically acceptable excipient claim 10 , carrier claim 10 , diluent claim 10 , or auxiliary agent to a subject.23. The method of claim 22 , wherein the ...

TREATMENT OF GLYCOGEN STORAGE DISEASE TYPE II

Methods of treating glycogen storage disease type II, by administering acid α-glucosidase, are described, as are compositions for use in treatment of glycogen storage disease type II. 1. A method of treating glycogen storage disease type II in an individual , comprising administering to the individual a therapeutically effective amount of human acid α-glucosidase at a regular interval.2. The method of claim 1 , wherein the glycogen storage disease type II is infantile glycogen storage disease type II.3. The method of claim 1 , wherein the glycogen storage disease type II is juvenile glycogen storage disease type II.4. The method of claim 1 , wherein the glycogen storage disease type II is adult-onset glycogen storage disease type II.5. The method of claim 1 , wherein the therapeutically effective amount of human acid α-glucosidase is less than about 15 mg of acid α-glucosidase per kilogram of body weight of the individual.6. The method of claim 5 , wherein the therapeutically effective amount of human acid α-glucosidase is about 1-10 mg of acid α-glucosidase per kilogram of body weight of the individual.7. The method of claim 5 , wherein the therapeutically effective amount of human acid α-glucosidase is about 5 mg of acid α-glucosidase per kilogram of body weight of the individual.8. The method of claim 1 , wherein the human acid α-glucosidase is recombinant human acid α-glucosidase.9. The method of claim 1 , wherein the human acid α-glucosidase is a precursor of recombinant human acid α-glucosidase.10. The method of claim 9 , wherein the recombinant human acid α-glucosidase is produced in Chinese hamster ovary cells.11. The method of claim 1 , wherein the regular interval is monthly.12. The method of claim 1 , wherein the regular interval is bimonthly.13. The method of claim 1 , wherein the regular interval is weekly.14. The method of claim 1 , wherein the regular interval is twice weekly.15. The method of claim 1 , wherein the regular interval is daily.16. The ...

Companion diagnostic for anti-hyaluronan agent therapy and methods of use thereof

Methods and diagnostic agents for identification of subjects for cancer treatment with an anti-hyaluronan agent, such as a hyaluronan-degrading enzyme, are provided. Diagnostic agents for the detection and quantification of hyaluronan in a biological sample and monitoring cancer treatment with an anti-hyaluronan agent, for example a hyaluronan-degrading enzyme, are provided. Combinations and kits for use in practicing the methods also are provided. 1. A method for selecting a subject for treatment of a tumor with an anti-hyaluronan agent , comprising:a) contacting a tissue or body fluid sample from a subject with a tumor or cancer with a hyaluronan binding protein (HABP) molecule, wherein the HABP has not been prepared from or isolated from animal cartilage;b) detecting binding of the hyaluronan binding protein to the sample, thereby determining the amount of hyaluronan in the sample, wherein if the amount of hyaluronan in the sample is at or above a predetermined threshold level, selecting the subject for treatment with an anti-hyaluronan agent; andc) treating the selected subject with an anti-hyaluronan agent.2. The method of claim 1 , wherein the predetermined threshold level is high HA.3. The method of claim 1 , wherein:the predetermined threshold level is at least or above 0.025 μg HA/ml of sample; or{'sup': +2', '+3, 'the predetermined threshold is an HA score of at least +2 (HA) or at least +3 (HA); or'}the predetermined threshold level is at least a percent HA positive pixels in tumor (cells and stroma) to total stain in tumor tissue of at least 10%, 10% to 25% or greater than 25%.4. The method of claim 1 , wherein:the HABP molecule comprises a link module; orthe HABP molecule comprises a G1 domain of a type C hyaluronan binding protein.5. The method of claim 4 , wherein the link module or G1 domain is the only HABP portion of the molecule.6. The method of claim 4 , wherein the HABP molecule comprises a link module and the link module is selected from among ...

BIODEGRADABLE PHASE SEPARATED SEGMENTED MULTI BLOCK CO-POLYMERS AND RELEASE OF BIOLOGICALLY ACTIVE POLYPEPTIDES

The invention is directed to biodegradable, thermoplastic, phase separated segmented multi-block copolymers. The copolymers of the present invention find use in various biomedical applications as well as in pharmaceutical applications. Provided is a composition for the controlled release of at least one biologically active polypeptide to a host, comprising the at least one biologically active polypeptide encapsulated in a matrix comprising at least one phase separated, thermoplastic multi-block copolymer, the copolymer being characterized in that (i) it comprises at least two hydrolysable segments chosen from prepolymer (A) and prepolymer (B), prepolymer (A) having a Tg lower than 37° C. and prepolymer (B) having a Tm of 40° C.-100° C. under physiological conditions; (ii) the segments being linked by a multifunctional chain-extender; (iii) the segments are randomly distributed over the polymer chain; and (iv) prepolymer (A) contains a segment that is derived from a water soluble polymer. 1. A composition for the controlled release of at least one biologically active polypeptide to a host , comprising the at least one biologically active polypeptide encapsulated in a matrix comprising at least one phase separated , thermoplastic multi-block copolymer , the copolymer being characterized in that:(v) it comprises at least two hydrolysable segments chosen from prepolymer (A) and prepolymer (B), prepolymer (A) having a Tg lower than 37° C. and prepolymer (B) having a Tm of 40° C.-100° C. under physiological conditions;(vi) the segments being linked by a multifunctional chain-extender;(vii) the segments are randomly distributed over the polymer chain;(viii) prepolymer (A) contains a segment that is derived from a water soluble polymer.2. Composition according to claim 1 , wherein said chain-extender is a difunctional aliphatic chain-extender claim 1 , preferably a diiosocyanate.3. Composition according to claim 1 , wherein prepolymer (A) comprises ester and/or carbonate ...

Microfabricated nanopore device for sustained release of therapeutic agent

A drug delivery device that includes a capsule for implantation into the body; the capsule further includes a reservoir for containing a substance such as a therapeutic agent, at least one port for allowing the substance to diffuse from or otherwise exit the reservoir, and a nanopore membrane in communication with the capsule at or near the exit port for controlling the rate of diffusion of the substance from the exit port. The device also includes an optional screen for providing structural stability to the nanopore membrane and for keeping the pores of the nanopore membrane clear. One embodiment of the drug delivery device includes an osmotic engine internal to the device for creating fluid flow through the device.

STANDARDIZED BEE VENOM PREPARATION

Bee venom may be administered in a standardized formulation with or without relatively small amounts of anesthetic. In particular, the results of the combination of venom and anesthetic dramatically decreased pain and discomfort for patients undergoing apitherapy. 1. A standardized bee venom preparation comprising a liquid carrier , from about 0.1 milligram (mg) to about 1.0 mg of pure melittin , and from about 400 microgram (mcg) to about 4 ,500 mcg of total protein per milliliter (mL) of said standardized bee venom preparation , wherein said standardized bee venom preparation exhibits 40 to 100 honey bee hyaluronidase units per mL (HHU/mL) of hyaluronidase activity when diluted to 100 mcg/mL and is capable of inhibiting gelatin induced aggregation of erythoricytes of 3-5 millimeter per hour (mm/H).2. The standardized bee venom preparation of claim 1 , wherein the liquid carrier is sterile deoinized water or physiological saline solution.3. The standardized bee venom preparation of claim 1 , further comprising an excipient selected from the group consisting of a viscosity modifier claim 1 , preservative claim 1 , additive claim 1 , sodium chloride claim 1 , saccharide claim 1 , benzyl alcohol claim 1 , methyl paraban and mixtures thereof.4. The standardized bee venom preparation of claim 1 , further comprising an anesthetic.5. The standardized bee venom preparation of claim 4 , wherein said anesthetic is selected from the group consisting of ambucaine claim 4 , amolanone claim 4 , amylocalne hydrochloride claim 4 , benoxinate claim 4 , benzocaine claim 4 , betoxycaine claim 4 , biphenamine claim 4 , bupivacaine claim 4 , butacaine claim 4 , butamben claim 4 , butanilicaine claim 4 , butethamine claim 4 , butoxycaine claim 4 , carticaine claim 4 , chloroprocaine hydrochloride claim 4 , cocaethylene claim 4 , cocaine claim 4 , cyclomethycaine claim 4 , dibucaine hydrochloride claim 4 , dimethisoquin claim 4 , dimethocaine claim 4 , diperodon hydrochloride claim 4 , ...

AGENT FOR USE IN THE CASE OF FRUCTOSE INTOLERANCE

5-D-fructose dehydrogenase, optionally in combination with invertase and/or maltase and/or glucose isomerase, may be used to treat fructose intolerance. Other embodiments are also disclosed. 1139-. (canceled)140. A method of treating or reducing the effects in a subject of a condition selected from fructose intolerance and impaired fructose metabolism , the method comprising administering to a subject in need of such treatment or reduction an efficacious amount of 5-D-fructose dehydrogenase.141. A method according to wherein said condition is fructose intolerance that is selected from the group consisting of (a) hereditary fructose intolerance claim 140 , (b) intestinal fructose intolerance claim 140 , (c) fructose intolerance that is due to a lack of fructose 1 claim 140 ,6-diphosphatase and (d) combinations thereof.142. (canceled)143. A method according to claim 140 , wherein said 5-D-fructose dehydrogenase is administered with a second enzyme which cleaves fructose from a sugar which is more complex than fructose.144. A method according to wherein said second enzyme is selected from the group consisting of invertase claim 143 , maltase and combinations thereof.145. A method according to claim 140 , wherein said administration comprises oral administration.146. A mammalian ingestible composition of matter which is adapted for oral administration selected from a pharmaceutical composition and a dietary supplement claim 140 , said composition of matter being in unit dosage form claim 140 , said composition of matter comprising 5-D-fructose dehydrogenase and a carrier or excipient that is acceptable for use in pharmaceutical compositions or foodstuffs.147148-. (canceled)149. A composition of matter according to which is in a form selected from (a) the group consisting of a tablet claim 146 , capsule claim 146 , gel cap claim 146 , pellet and dragee claim 146 , (b) powder or (c) liquid form as solution claim 146 , drops claim 146 , suspension or gel.150152-. (canceled ...

METHODS OF TREATING BEHAVIORAL SYMPTOMS OF NEUROLOGICAL AND MENTAL DISORDERS

Disclosed herein are methods of using coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations for treatment of subjects having behavioral disorders, neurological disorders or mental health disorders. Disclosed herein are methods of treating core and non-core symptoms of behavioral disorders, neurological disorders or mental health disorders. Also disclosed herein are products for use in methods of treatment and methods of making the same. 1. A method of treating a subject with one or more symptoms of an ASD , comprising:administering to the subject a pharmaceutical composition comprising one or more excipients and a therapeutic composition, wherein the therapeutic composition comprises protease, amylase and/or lipase,wherein the subject exhibits improvement in one or more symptoms of an ASD comprising:(a) protein intake, fat intake, carbohydrate intake, vitamin intake, diarrhea, constipation, seizures, and/or bone fragility; and/or(b) hyperactivity, irritability, agitation, obsessive compulsive behavior, eye contact, speech, lethargy, hypersensitivity, stereotypy, toilet training, non-compliance, inattention, aggression, impulsivity, conduct disorder, or oppositional defiance and/or social withdrawal and wherein the subject has a greater improvement in the one or more symptoms of an ASD after administration of the pharmaceutical composition than a subject a subject with one or more symptoms of an ASD administered a placebo.23-. (canceled)4. The method of claim 1 , wherein the subject exhibits a 10% or greater improvement in one or more symptoms of an ASD after administration of the pharmaceutical composition in comparison to before the subject was administered the pharmaceutical composition.58-. (canceled)9. The method of claim 1 , wherein the greater the amount of daily protein claim 1 , fat claim 1 , carbohydrate and/or vitamin intake (by weight) consumed by the subject after administration of ...

METHOD OF REGULATING FERTILIZING ABILITY USING CYCLIC ADP-RIBOSE AND CD38

The present invention relates to a pharmaceutical composition for promoting fertilization comprising cyclic ADP-ribose or its derivative, CD38 and to a method of promoting fertilization by promoting the synthesis of cyclic ADP-ribose to increase sperm motility. Also, the present invention relates to a pharmaceutical composition for contraception and a method for inhibiting fertilization, which can inhibit the expression or function of cyclic ADP-ribose to reduce sperm motility, thereby inhibiting fertilization. 1. (canceled)2. A pharmaceutical composition for promoting fertilization comprising CD38.34-. (canceled)5. A method of promoting fertilization by increasing the motility of sperm , the method comprising a step of promoting the synthesis of cyclic ADP-ribose.6. The method of claim 5 , wherein the cyclic ADP-ribose is synthesized in prostasome-bound sperm.7. The method of claim 5 , wherein the method further comprises a step of treating the sperm with progesterone.8. The method of claim 7 , wherein the treatment with the progesterone promotes intracellular calcium release to induce a continuous increase in calcium.9. A pharmaceutical composition for contraception comprising an antagonist of cyclic ADP-ribose.10. The pharmaceutical composition of claim 9 , wherein the antagonist is 8-Br-cADPR or 8-amino-cADPR.11. The pharmaceutical composition of claim 9 , wherein the cyclic ADP-ribose is synthesized in CD38 contained in prostasome.12. The pharmaceutical composition of claim 9 , wherein the antagonist inhibits a pattern of a continuous increase in calcium by progesterone.13. A method for inhibiting fertilization comprising inhibiting cyclic ADP-ribose.14. The method of claim 13 , wherein the inhibition is performed by treatment with an antagonist of the cyclic ADP-ribose.15. The pharmaceutical composition of claim 10 , wherein the antagonist inhibits a pattern of a continuous increase in calcium by progesterone. 1. Field of the InventionThe present invention ...

Controlled release compositions

An improved composition for controlling the release profile of an active compound through the intestinal tract comprises particles, especially pellets, containing the active compound, which are coated with a pH dissolution dependent coating material or a polymethacrylate material, which is preferably pH dissolution dependent, to a certain thickness depending upon the location and rate of release of the active compound that is desired. In preferred compositions, two or more pluralities of particles, in which particles of each plurality are coated with pH dissolution dependent coating material or polymethacrylate material to a different thickness to those of each other plurality, are contained within an enterically coated capsule and provide release of the active compound at various desired locations in the intestinal tract.

Methods and materials for treatment of pompe's disease

This document relates to molecular complexes having acid alpha glucosidase activity and at least one modification that results in enhanced ability of the molecular complex to be transported to the interior of a mammalian cell.

Composition and lipid formulation of a hyaluronan-degrading enzyme and the use thereof for treatment of benign prostatic hyperplasia

Provided are compositions and formulations or co-formulations containing a hyaluronan degrading enzyme. The compositions, formulations or co-formulations can also contain another therapeutic agent, such as one that is suitable for treatment of Benign Prostatic Hyperplasia, for example, a 5-alpha reductase inhibitor. The compositions and formulations can be used for the treatment of Benign Prostatic Hyperplasia. The compositions and formulations can be provided in combinations with one or more other agents for the treatment of Benign Prostatic Hyperplasia. 1. A multivesicular liposome having a hyaluronan-degrading enzyme encapsulated therein , comprising:a) a neutral lipid;an amphipathic lipid; anda hyaluronan-degrading enzyme, wherein the concentration of the hyaluronan-degrading enzyme is between or about between 0.1 mg/mL to 1 mg/mL; orb) a neutral lipid;an amphipathic lipid;a hyaluronan-degrading enzyme; andhyaluronic acid in an amount sufficient to increase the encapsulation and enzymatic activity of the hyaluronan-degrading enzyme.2. The multivesicular liposome of claim 1 , wherein the multivesicular liposome is of a) and further comprises hyaluronic acid in an amount sufficient to increase the encapsulation and enzymatic activity of the hyaluronan-degrading enzyme.3. The multivesicular liposome of claim 1 , wherein the hyaluronic acid maintains the total activity of the enzyme of at least 40 claim 1 ,000 U/mg.4. The multivesicular liposome of claim 2 , wherein the hyaluronic acid maintains the total activity of the enzyme of at least 40 claim 2 ,000 U/mg.5. The multivesicular liposome of claim 1 , wherein the hyaluronan-degrading enzyme is a hyaluronidase claim 1 , a chondroitinase or a lyase.6. The multivesicular liposome of claim 5 , wherein the hyaluronan-degrading enzyme is a hyaluronidase that is a PH20 hyaluronidase.7. The multivesicular liposome of claim 6 , wherein the PH20 is soluble or is a form that is secreted when expressed.8. The multivesicular ...

LYSOZYME GEL FORMULATIONS

The present invention relates to formulations of gelled lysozyme achieved by the addition of water to a lysozyme suspension in a solvent, such as an alcohol, with retention of enzymatic activity. It was surprisingly discovered that lysozyme itself is a gelling substance (self-gel) and, therefore, it can be advantageously formulated into topical compositions without the addition of other gelling substances such as cellulose, starch or other polysaccharides. The activity of the lysozyme is enhanced as compared to other formulations of comprising lysozyme. The formulations contained in the present invention are useful in methods in the fields of therapeutics, disinfectants, sanitizers, personal hygiene, and cosmetics for human and veterinary use. 1. A composition comprising gelled lysozyme , water and a solvent , wherein the gelled lysozyme retains at least one activity.2. The composition according to claim 1 , wherein the solvent is an organic solvent.3. The composition according to claim 2 , wherein the organic solvent is miscible with water but one in which lysozyme does not substantially dissolve.4. The composition according to claim 2 , wherein the organic solvent is an alcohol.5. The composition according to claim 4 , in which the alcohol is selected from the group consisting of ethanol claim 4 , methanol claim 4 , propanol claim 4 , butanol claim 4 , isopropyl alcohol claim 4 , isobutyl alcohol claim 4 , isoamyl alcohol claim 4 , isopropylalcohol claim 4 , benzylalcohol claim 4 , and polyvinylalcohol.6. The composition according to claim 2 , in which the organic solvent is selected from the group consisting of dioxane claim 2 , mercaptoethanol and acetonitrile.7. The composition according to claim 1 , in which the lysozyme is a free base.8. The composition according to claim 1 , in which the lysozyme is a salt.9. The composition according to claim 8 , in which the lysozyme is an organic salt.10. The composition according to claim 8 , in which the lysozyme is an ...

THERAPEUTIC AGENT FOR DISC HERNIATION

The present invention provides a therapeutic agent for disc herniation, which has extremely few adverse side effects, can achieve a prolonged pain-ameliorating effect when administered in only a single dose, and can exhibit a high therapeutic effect and high safety in clinical applications. The present invention relates to a therapeutic agent for disc herniation, which is characterized by containing chondroitinase ABC as an active ingredient and being administered in such a manner that the ingredient can be administered into a human disk in an amount of 1-8 units per disk. 1. A therapeutic agent for disc herniation , which is characterized by containing chondroitinase ABC as an active ingredient and being administered in such a manner that the ingredient can be administered into a human disk in an amount of 1-8 units per disk.2. The therapeutic agent according to claim 1 , wherein the disc herniation is a lumbar disc herniation.3. The therapeutic agent according to claim 1 , wherein the chondroitinase ABC is derived from Proteus vulgaris.4. A formulation containing chondroitinase ABC for treating disc herniation by the administration into a human disk in an amount of 1-8 units per disk.5. The formulation according to claim 4 , wherein the formulation is a single dose formulation.6. The formulation according to claim 4 , wherein the formulation is an injection.7. The formulation according to claim 4 , wherein the disc herniation is a lumbar disc herniation.8. A method for treating disc herniation claim 4 , comprising administering chondroitinase ABC to a human disk of a patient with disc herniation in an effective amount of 1-8 units per disk.9. (canceled) The present invention relates to a therapeutic agent for disc herniation containing chondroitinase ABC as an active ingredient.Disc herniation is a disease that causes leg pain, low back pain, and the like due to the pressure on nerves of spinal cords, and the like, attributed to protrusion of the disc tissue into ...

COMPOSITION AND METHOD FOR MODULATING INFLAMMATORY MOLECULES WITH AMYLASE

A method and composition for treating in a mammalian subject a condition accompanied or caused by IgE mediated histamine release from mast cells comprising administering to a subject in need of such treatment a therapeutically effective amount of the pharmaceutical composition an amylase peptide or derivative thereof. 1. A method of modulating IgE mediated histamine release from an IgE receptor-positive cell capable of releasing histamine in-vitro or in-vivo comprising:providing an effective dose of an Amylase peptide or a derivative thereof to the IgE receptor-positive cell in-vitro or in-vivo under conditions that would permit binding of Amylase to free IgE in solution to form an IgE-Amylase binding pair thereby inhibiting the binding of free IgE to the IgE receptor-positive cell.2. The method of wherein the cell is a mast cell claim 1 , a basophil or an antigen-presenting dendritic cell.3. The method of wherein the Amylase peptide is pancreatic alpha-Amylase.4. The method of wherein the Amylase peptide is selected from SEQ ID NO 1-11 or a derivative thereof.5. The method of wherein the Amylase peptide derivative is a composition having at least 90% sequence homology with amino acids 417-427 of SEQ ID NO. 1 and at least 70% sequence homology with the remaining amino acids of SEQ ID NO 1.6. A method of treating Type I diabetes claim 4 , Type II diabetes claim 4 , Obesity claim 4 , or Insulin Resistance or secondary complications associated therewith including nephropathy claim 4 , neuropathy claim 4 , retinopathy or cardiovascular disease in a mammalian subject comprising:administering to said subject a therapeutically effective amount of an alpha-Amylase peptide or a derivative thereof.7. The method of wherein the alpha-Amylase is a peptide selected from SEQ ID NO 1-11 or a derivative thereof.8. The method of wherein the Amylase peptide derivative is a composition having at least 90% sequence homology with amino acids 417-427 of SEQ ID NO. 1 and at least 70% ...

Methods, Compounds and Compositions for Treatment of Influenza and Parainfluenza Patients

A method of reducing or treating parainfluenza or influenza virus infection in an immunocompromised patient by administering to the respiratory tract of the patient a composition comprising a therapeutically effective amount of protein having sialidase activity.

METHODS AND COMPOSITIONS FOR CNS DELIVERY OF B-GALACTOCEREBROSIDASE

The present invention provides, among other things, compositions and methods for CNS delivery of lysosomal enzymes for effective treatment of lysosomal storage diseases. In some embodiments, the present invention includes a stable formulation for direct CNS intrathecal administration comprising an B-Galactocerebrosidase protein, salt, and a polysorbate surfactant for the treatment of GLD Disease. 1. A stable formulation for intrathecal administration comprising a β-Galactocerebrosidase (GLC) protein , salt , a buffering agent , a stabilizing agent and a polysorbate surfactant.2. The stable formulation of claim 1 , wherein the GLC protein is present at a concentration up to approximately 300 mg/ml.3. (canceled)4. The stable formulation of claim 1 , wherein the GLC protein comprises an amino acid sequence of SEQ ID NO:1.5. The stable formulation of claim 1 , wherein the salt is NaCl.6. The stable formulation of claim 5 , wherein the NaCl is present at a concentration ranging from approximately 0-300 mM.7. (canceled)8. The stable formulation of claim 1 , wherein the polysorbate surfactant is selected from the group consisting of polysorbate 20 claim 1 , polysorbate 40 claim 1 , polysorbate 60 claim 1 , polysorbate 80 and combinations thereof.911-. (canceled)12. The stable formulation of claim 1 , wherein the buffering agent is selected from the group consisting of phosphate claim 1 , acetate claim 1 , histidine claim 1 , sccinate claim 1 , citrate claim 1 , Tris claim 1 , and combinations thereof.12a. (canceled)13. The stable formulation of claim 60 , wherein the phosphate is present at a concentration no greater than 20 mM.14. (canceled)15. The stable formulation of claim 1 , wherein the stabilizing agent is selected from the group consisting of sucrose claim 1 , glucose claim 1 , mannitol claim 1 , sorbitol claim 1 , PEG 4000 claim 1 , histidine claim 1 , arginine claim 1 , lysine claim 1 , phospholipids and combinations thereof.1617-. (canceled)18. The stable ...

Compositions for treating microbial infections

Certain embodiments are directed to methods of treating a condition associated with microbial infection in a subject having such a condition comprising administering to the subject a composition comprising an effective amount of (a) lysozyme and (b) N-acetyl glucosamine polymer.

Compositions and Methods for Altering Tissue Specificity and Improving AAV9-Mediated Gene Transfer

A method of altering the targeting and/or cellular uptake efficiency of an adeno-associated virus (AAV) viral vector having a capsid containing an AAV9 cell surface binding domain is described. The method involves modifying a clade F cell surface receptor which comprises a glycan having a terminal sialic acid residue and a penultimate β-galactose residue. The modification may involve retargeting the vector by temporarily functionally ablate AAV9 binding in a subset of cells, thereby redirecting the vector to another subset of cells. Alternatively, the modification may involve increasing cellular update efficiency by treating the cells with a neuraminidase to expose cell surface β-galactose. Also provided are compositions containing the AAV9 vector and a neuraminidase. Also provided is a method for purifying AAV9 using β-galactose linked to solid support. Also provided are mutant vectors which have been modified to alter their targeting specificity, including mutant AAV9 in which the galactose binding domain is mutated and AAV in which an AAV9 galactose binding domain is engineered. 1. A method of altering the targeting and/or cellular uptake efficiency of an adeno-associated virus (AAV) vector having a capsid from a clade F AAV , said method comprising delivering to a subject a composition which modifies the ability of a cell comprising a β-galactose residue to bind a clade F AAV.2. The method according to claim 1 , wherein the method comprises delivering to a subject having cells with a cell surface glycan having terminal sialic acid and a penultimate β-galactose said AAV viral vector in combination with a neuraminidase claim 1 , whereby the neuraminidase cleaves the terminal sialic acid and converts the penultimate β-galactose to a terminal β-galactose.3. The method according to claim 2 , wherein said method comprises pre-treating the subject with the neuraminidase.4. The method according to claim 2 , wherein said method comprises delivering to the subject said ...

ENHANCED THERAPEUTIC USAGE OF A PURINE NUCLEOSIDE PHOSPHORYLASE OR NUCLEOSIDE HYDROLASE

The use of a purine nucleoside phosphorylase or nucleoside hydrolase or a vector encoding expression of one of these enzymes is detailed along with the use of a prodrug cleaved by the purine nucleoside phosphorylase or nucleoside hydrolase for the preparation of a direct injection inhibition of replicating or non-replicating targeted cells. The targeted cells do not normally express the introduced purine nucleoside phosphorylase or nucleoside hydrolase. The enzyme and prodrug are amenable to intermixing and injection as a single dose or as separate injection or administration to the targeted cells. The substance and prodrug efficacy are enhanced through exposure of the targeted cells to X-ray radiation. Administration of a prodrug regardless of administration route to the targeted cells is effective in combination with X-ray radiation therapy to kill or inhibit function of the targeted cells. 110-. (canceled)11. A therapeutic comprising:a purine nucleoside phosphorylase or nucleoside hydrolase or a vector encoding expression thereof; anda prodrug in a sustained release carrier, said prodrug cleaved by said purine nucleoside phosphorylase or nucleoside hydrolase for direct prodrug injection inhibition of replicating or non-replicating targeted cells.1220-. (canceled)21. A process of inhibiting replicating or non-replicating targeted cells comprising:delivering a purine nucleoside phosphorylase or nucleoside hydrolase or a vector encoding expression thereof to the targeted cells; andinjecting a prodrug cleaved by said purine nucleoside phosphorylase or nucleoside hydrolase directly into proximity to the targeted cells to release a purine base cytotoxic to the targeted cells so as to inhibit the targeted cells.22. The process of wherein the targeted cells define a tumor.23. The process of wherein said purine nucleoside phosphorylase or nucleoside hydrolase is delivered with a viral vector containing a nucleic acid encoding said purine nucleoside phosphorylase or said ...

Long lasting absorption of flavonoids

The present invention relates to methods for a ong-term and sustained release of flavonoids, in particular rhamnose-containing flavonoids, and for prolonging the uptake of said flavonoids in the gastro-intestinal tract. It further relates to compositions comprising said flavonoid and α-rhamnosidase. It also encompasses compositions comprising hesperidin and hesperetin-7-gluoside.

ORALLY ADMINISTERED PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF IRRITABLE BOWEL SYNDROME, COMPRISING AN INTESTINAL MOTILITY MODIFIER, AN AGENT THAT PREVENTS GAS RETENTION, AND DIGESTIVE ENZYMES, AND PREPARATION METHOD THEREOF

A pharmaceutical composition or formulation adapted for oral administration in tablet, coated tablet, capsule or reconstitutable powder form for the prevention or treatment of intestinal disorders such irritable bowel syndrome, also known as irritable colon syndrome, based on an intestinal motility modifier, an agent that prevents gas retention, of digestive enzymes, a binding agent, a diluting agent, an absorbent agent, a lubricant, aglidant, and an disintegrating agent or suspending agent, effective in the normalization of intestinal disorders, to achieve an analgesic activity, to achieve an anti-spasmic activity and to reduce the symptoms associated with intestinal gas such as distention, abdominal pain and flatulence. 1. A pharmaceutical composition or formulation adapted for oral administration in tablet , coated tablet or capsule form for the prevention or treatment of intestinal disorders , the formulation is composed of: an intestinal motility modifier , an agent , which prevents the retention of gases , a digestive enzyme , a binding agent , a diluting agent , an absorbing agent , a disintegrating agent , a lubricating agent and a gliding agent.2. The pharmaceutical formulation in accordance with claim 1 , wherein the intestinal motility modifier is selected from a group which consists of: trimebutine claim 1 , fenoverine claim 1 , mebeverine claim 1 , dicycloverine claim 1 , ethyl bromide claim 1 , alosetron claim 1 , tegaserod claim 1 , loperamide claim 1 , phloroglucinol claim 1 , Trimethylphloroglucinol claim 1 , Butylscopolamine claim 1 , and pargeverine.3. The pharmaceutical formulation in accordance with claim 2 , wherein the intestinal motility modifier is trimebutine and its acceptable pharmaceutical salts.4. The pharmaceutical formulation in accordance with claim 2 , wherein the intestinal motility modifier is fenoverine and its acceptable pharmaceutical salts.5. The pharmaceutical formulation in accordance with claim 2 , wherein the intestinal ...

Administration of Enzyme and Prebiotic Combinations that Enhance Probiotic Growth and Efficacy

This disclosure relates to enhancing growth and/or activity of lactobacilli using a prebiotic formulation which includes iso-malto oligosaccharides and α-galactosidase; and to enhancing growth and/or activity of bifidobacteria using a prebiotic formulation which includes iso-malto oligosaccharides and β-glucanase. Other combinations of fibers and enzymes are described below which also stimulate growth and activity of lactobacilli or bifidobacteria. These combinations of enzymes and prebiotics can be taken separately or added to foods, including desserts.

METHOD AND APPARATUS FOR TREATMENT OF CARDIAC DISORDERS

The present invention is directed to systems and methods for delivering therapy for a cardiac disorder, wherein the system comprises a source for supplying a protein formulation containing a protein that is otherwise deficient in cardiac cells in a patient with a cardiac disorder, and a catheter having a proximal end and a distal end for delivering the protein formulation to the pericardial sac region of a human heart. 1. (canceled)226-. (canceled)27. A method comprising:delivering a therapeutic protein formulation from an implantable source through an implantable catheter directly to a pericardial sac region of a heart of a patient,wherein the patient has a cardiac disorder caused by a protein deficiency due to a gene mutation,wherein the therapeutic protein formulation comprises a protein in a form that is deficient in cardiac cells of the patient due to the gene mutation, andwherein the therapeutic protein formulation is delivered at a rate based on the sequence of the patient's gene mutation.28. The method of claim 27 , wherein the protein formulation comprises at least one species operable for maintaining a desired pH.29. The method of claim 27 , wherein the implantable source comprises a refillable reservoir to store the protein formulation.30. The method of claim 27 , wherein the cardiac disorder is glycogen storage disease Type II or Fabry disease.31. The method of claim 30 , wherein the protein is lysosomal acid α-glucosidase or α-galactosidase.32. The method of claim 27 , wherein the cardiac disorder is glycogen storage disease Type II and the protein is lysosomal acid α-glucosidase.33. The method of claim 27 , wherein the cardiac disorder is Fabry disease and the protein is α-galactosidase.34. The method of claim 27 , further comprising administering an RNA interference therapy to the patient to inhibit production of a mutated protein resulting from the gene mutation.35. The method of claim 27 , wherein the rate of delivery of the therapeutic protein ...

TREATMENT OF OPHTHALMIC CONDITIONS

Ophthalmic conditions such as presbyopia, myopia, and astigmatism can be corrected by the use of a molding contact lens in combination with a pharmaceutical composition suitable for delivery to the eye. The molding contact lenses are preferably commercially available and are not specifically designed for orthokeratology. The agents in the pharmaceutical compositions such as hyaluronase allow the cornea of the eye to be molded in order to correct the refractive error of the eye. The contact lenses and the pharmaceutical composition induce a change in the radius of curvature of the anterior surface of the cornea, thereby correcting the refractive error of the eye. One advantage of the inventive technique is that the patient with his or her own individual visual needs guides the treatment until the patient near and far visual needs are met. The present invention also provides for kits, which contain molding contact lenses, pharmaceutical composition suitable for delivery to the eye, and instructions, useful in the inventive system. 149-. (canceled)50. A non-invasive method for treating myopia , the method comprising steps of:providing a contact lens;providing eye drops comprising an effective amount of hyaluronidase and collagenase, wherein the collagenase is not matrix metalloproteinase 1 or matrix metalloproteinase 2;applying the contact lens to an eye of a patient suffering from myopia; andapplying the eye drops to the eye of the patient;wherein the treatment corrects the patient's far vision, and the treatment results in corrected vision for at least 6 months.51. A non-invasive method for treating hyperopia , the method comprising steps of:providing a contact lens;providing eye drops comprising an effective amount of hyaluronidase and collagenase, wherein the collagenase is not matrix metalloproteinase 1 or matrix metalloproteinase 2;applying the contact lens to an eye of a patient suffering from hyperopia; andapplying the eye drops to the eye of the patient; ...

NOVEL ENDOLYSIN

The present invention relates to a polypeptide with endolysin activity comprising an amino acid sequence according to SEQ ID No. 1 and fragments or derivatives thereof, or fusion proteins derived thereof. Moreover, the present invention relates to nucleic acid molecules encoding said polypeptide or fusion protein, vectors comprising said nucleic acid molecules and host cells comprising either said nucleic acid molecules or said vectors. In addition, the present invention relates to said polypeptide, fragment, derivative or fusion protein for use as a medicament, in particular for the treatment or prevention of Gram-negative bacterial infections, as diagnostic means, as cosmetic substance or as sanitizing agent. The present invention also relates to the use of said polypeptide, fragment, derivative or fusion protein for the treatment or prevention of Gram-negative bacterial contamination of foodstuff, of food processing equipment, of food processing plants, of surfaces coming into contact with foodstuff, of medical devices, of surfaces in hospitals and surgeries. Furthermore, the present invention relates to a pharmaceutical composition comprising said polypeptide, fragment, derivative or fusion protein. 1. A polypeptide having endolysin activity comprising an amino acid sequence according to SEQ ID NO: 1 or a fragment or derivative thereof.2. The polypeptide according to claim 1 , wherein the fragment comprises an amino acid sequence according to SEQ ID NO: 3 and/or 5.3. The polypeptide according to claim 1 , wherein the derivative has a deletion claim 1 , addition claim 1 , insertion and/or substitution in the amino acid sequence according to SEQ ID NO: 1 claim 1 , 3 claim 1 , and/or 5.4. The polypeptide according to claim 1 , wherein the polypeptide is fused at the N- or C-terminus to a peptide stretch having membrane or LPS disrupting activity.5. The polypeptide according to comprising additionally a tag claim 1 , preferably a His6-tag.6. The polypeptide ...

USE OF BETA-1,3 (4)-ENDOGLUCANOHYDROLASE, BETA-1,3 (4)-GLUCAN, DIATOMACEOUS EARTH, MINERAL CLAY AND GLUCOMANNAN TO AUGMENT IMMUNE FUNCTION

A method for the augmentation of immune function is described. The invention comprises a combination of β-1,3 (4)-endoglucanohydrolase, β-1,3 (4)-glucan, diatomaceous earth, mineral clay and glucomannan, which is fed to or consumed by mammalian or avian species in amounts sufficient to augment immune function. The invention described may be admixed with feeds or foods, incorporated into pelleted feeds or foods or administered orally to mammalian and avian species. 1. A method for reducing a stress effect in an animal , comprising administering to an animal having an increased stress indicator a composition comprising β-glucans , β-1 ,3 (4)-endoglucanohydrolase , silica , a mineral clay , and mannans , wherein the animal is selected from mammalian and avian species , thereby reducing a stress effect in the animal.2. The method of where the increased stress indicator is an elevated stress hormone level and the stress effect is immunosuppression mediated by the elevated stress hormone level.3. The method of where the elevated stress hormone is cortisol claim 2 , hydrocortisone claim 2 , corticosterone claim 2 , or a combination thereof.4. The method of where the elevated stress hormone level includes elevated glucocorticoids.5. The method of where the composition is administered to the animal at or around a time of parturition.6. The method of claim 1 , further comprising administering the composition to the animal as a prophylactic to prevent colonization or growth of pathogenic fungal or bacterial species in the animal.7. The method of where administering the composition augments the animal's innate immune function.8. The method of where augmenting the animal's innate immune function includes increasing the expression of L-selectin claim 7 , interleukin-1β claim 7 , or a combination thereof.9. The method of where the silica is provided by diatomaceous earth.10. The method of where the mannans comprise glucomannan.11. The method of where the mineral clay comprises ...

Novel Pharmaceutical Preparation for Preeclampsia, Eclampsia, and Toxemia and Their Related Symptoms and Related Disorders of Pregnancy

A therapeutic agent for the treatment of toxemia, preeclampsia and eclampsia and the method for preparing the therapeutic agents is disclosed. The therapeutic agent is a stable pharmaceutical preparation containing, but not limited to, digestive/pancreatic enzymes. The therapeutic agent may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic agent may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using of a biomarker, the presence of chymotrypsin in the maternal GI tract to determine the likelihood of developing preeclampsia, pregnancy induced hypertension, and eclampsia/toxemia is disclosed. 1. A method for treating an individual exhibiting one or more symptoms of preeclampsia , the method comprising administering a therapeutically effective amount of digestive enzymes to the individual.2. The pharmaceutical preparation of claim 1 , wherein the digestive enzyme is selected from the group consisting of: amylase claim 1 , lipase claim 1 , protease claim 1 , and a combination thereof.3. The pharmaceutical preparation of claim 1 , wherein the digestive enzyme is further selected from the group consisting of: chymotrypsin claim 1 , trypsin claim 1 , pancreatin claim 1 , papaya claim 1 , papain claim 1 , and a combination thereof.4. The pharmaceutical preparation of claim 1 , wherein the enzymes are derived from a source selected from the group consisting of animal enzymes claim 1 , plant enzymes claim 1 , synthetic enzymes claim 1 , and a combination thereof.5. The pharmaceutical preparation of wherein the preparation is manufactured using a technology selected from the group consisting of Proslv® technology claim 1 , enteric coating claim 1 , lipid encapsulation claim 1 , direct compression claim 1 , dry granulation claim 1 , wet granulation claim 1 , and a combination thereof.6. The pharmaceutical preparation of claim 1 , wherein the preparation is administered orally via ...

Treatment of Pompe's Disease

The invention provides methods of treating Pompe's disease using human acid alpha glucosidase. A preferred treatment regime comprises administering greater than 10 mg/kg body weight per week to a patient. 1. A method of treating a patient with Pompe's disease , comprising:administering to the patient a therapeutically effective amount of human acid alpha glucosidase.2. The method of claim 1 , wherein the patient is administered at least 10 mg/kg body weight per week.3. The method of claim 1 , wherein the patient is administered at least 60 mg/kg body weight per week.4. The method of claim 1 , wherein the patient is administered at least 120 mg/kg body weight per week.57-. (canceled)8. The method of claim 1 , wherein the alpha-glucosidase is administered intravenously.10. The method of claim 1 , wherein the patient has infantile Pompe's disease.11. The method of claim 10 , wherein the patient survives to be at least one year old.12. The method of claim 1 , wherein the patient has juvenile Pompe's disease.13. The method of claim 1 , wherein the patient has adult Pompe's disease.14. The method of claim 1 , wherein the alpha-glucosidase is predominantly in a 110 kD form.15. The method of claim 1 , further comprising monitoring a level of human acid alpha glucosidase in the patient.1626-. (canceled)27. A pharmaceutical composition comprising human acid alpha .glucosidase claim 1 , human serum albumin claim 1 , and a sugar in a physiologically acceptable buffer in sterile form.28. The pharmaceutical composition of comprising human acid alpha glucosidase claim 27 , human serum albumin claim 27 , and glucose in sodium phosphate buffer.29. A pharmaceutical composition comprising alpha glucosidase claim 27 , mannitol and sucrose in an aqueous solution.30. The pharmaceutical composition of claim 27 , wherein the sugar comprises mannitol and sucrose and the concentration of mannitol is 1-3% w/w of the aqueous solution and the concentration of sucrose is 0.1 to 1% w/w of the ...

SUBCUTANEOUS ADMINISTRATION OF ALPHA-GALACTOSIDASE A

The invention relates, in part, to improved methods of administering α-galactosidase A for the treatment of α-galactosidase A deficiencies including Fabry disease. 1. A composition comprising from about 1 mg/ml to about 60 mg/ml α-Gal A , from about 2% to about 10% (w/v) carbohydrate , from about 5 mM to about 10 mM citrate , up to 3% (v/v) excipient , from about 0.05% to about 0.5% (v/v) surfactant , and having a pH of 6.0.24-. (canceled)5. A composition comprising 30 mg/ml of α-Gal A , 5% (w/v) sucrose , 5 mM citrate , between about 1% and 2.5% (v/v) glycerol , and 0.05% (v/v) poloxamer 188 , and having a pH of 6.0.6. A composition comprising from about 1 mg/ml to about 60 mg/ml α-Gal A , from about 2% to about 10% (w/v) carbohydrate , from about 5 mM to about 10 mM citrate , about 1% or less of an antimicrobial agent , up to 3% (v/v) excipient , and having a pH of 6.0.79-. (canceled)10. A composition comprising 30 mg/ml of α-Gal A , 5% (w/v) sucrose , 5 mM citrate , 1% or less (v/v) benzyl alcohol , up to 3% (v/v) glycerol , and having a pH of 6.0.11. A method of enhancing delivery of α-Gal A to the kidneys in an individual with Fabry disease , the method comprising administering human α-Gal A to the individual by an oral route or a parenteral route.12. The method of claim 11 , wherein the parenteral route is selected from the group consisting of the following routes: intra-arterial claim 11 , intraperitoneal claim 11 , ophthalmic claim 11 , intramuscular claim 11 , vaginal claim 11 , intraorbital claim 11 , intracerebral claim 11 , intradermal claim 11 , intracranial claim 11 , intraspinal claim 11 , intraventricular claim 11 , intrathecal claim 11 , intracisternal claim 11 , intracapsular claim 11 , intrapulmonary claim 11 , intranasal claim 11 , transmucosal claim 11 , transdermal and inhalation.1314-. (canceled)15. The method of claim 11 , wherein α-Gal A is administered in sufficient dose to result in kidney α-Gal A levels in the individual that result in an ...

Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases

The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated form of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity. 1. A pharmaceutical composition , comprising:a) a soluble neutral active human hyaluronidase glycoprotein (sHASEGP); and{'i': Haemophilus Influenza', 'Hemophilus influenza', 'Bacillus, "b) a pharmacologic or pharmaceutically effective agent selected from among Adalimumabs, Agalsidase Betas, Alefacepts, Ampicillins, Anakinras, Antipoliomyelitic Vaccines, Anti-Thymocytes, Azithromycins, Becaplermins, Caspofungins, Cefazolins, Cefepimes, Cefotetans, Ceftazidimes, Ceftriaxones, Cetuximabs, Cilastatins, Clavulanic Acids, Clindamycins, Darbepoetin Alphas, Daclizumabs, Diphtheria, Diphtheria antitoxins, Diphtheria Toxoids, Efalizumabs, Epinephrines, Erythropoietin Alphas, Etanercepts, Filgrastims, Fluconazoles, Follicle-Stimulating Hormones, Follitropin Alphas, Follitropin Betas, Fosphenyloins, Gadodiamides, Gadopentetates, Gatifloxacins, Glatiramers, GM-CSF's, Goserelins, Goserelin acetates, Granisetrons, B's, Haloperidols, Hepatitis vaccines, Hepatitis A Vaccines, Hepatitis B Vaccines, Immunoglobulins, vaccines, Influenza Virus Vaccines, ...

PHARMACEUTICAL COMPOSITION FOR TREATING LYSOSOMAL STORAGE DISEASE

The purpose of the present invention is to provide, in a simple and also inexpensive manner, a pharmaceutical composition which comprises a plurality of lysosomal enzymes and is effective in treating lysosomal storage disease caused by a deficiency in a plurality of lysosomal enzymes. Provided is a pharmaceutical composition for treating lysosomal storage disease, the composition comprising as an active ingredient a lysosomal enzyme group obtained from cells derived from a subject who does not suffer from lysosomal storage disease. 111.-. (canceled)12. A pharmaceutical composition for treating mucolipidosis type II or type III , comprising a group of purified lysosomal enzymes as an active ingredient , wherein the group of lysosomal enzymes is obtained by culturing a cell , and the group of purified lysosomal enzymes comprises at least α-mannosidase , α-fucosidase , α-galactosidase , α-glucosidase , β-galactosidase , β-glucosidase , β-hexosaminidase , β-glucuronidase , galactocerebrosidase , and cathepsin.13. The pharmaceutical composition according to claim 12 , wherein the cell has the ability to add a mannose 6-phosphate residue to lysosomal enzymes.14. The pharmaceutical composition according to claim 12 , wherein the cell is derived from a subject not suffering from lysosomal disease.15. The pharmaceutical composition according to claim 12 , wherein the group of lysosomal enzymes is obtained by a method comprising the following steps:adding to a cell one or more reagents selected from the group consisting of amphiphilic amines, lysosome-tropic amines, ionophores, and V-ATPase inhibitors, followed by culturing;collecting a culture supernatant; andpurifying the obtained culture supernatant.16. The pharmaceutical composition according to claim 15 , wherein the reagent(s) is selected from the group consisting of ammonium chloride claim 15 , chloroquine claim 15 , monencin claim 15 , nigericin claim 15 , and bafilomycin A1.17. The pharmaceutical composition ...

SCAVENGER RECEPTOR UPTAKE FOR FABRY DISEASE ENZYME REPLACEMENT THERAPY

The present invention relates to a composition comprising a lysosomal enzyme conjugated to a negatively charged scavenger receptor ligand. In some embodiments, the lysosomal enzyme is conjugated to the scavenger receptor ligand by way of a linker. The present invention also relates to a composition comprising lysosomal enzyme encapsulated by a liposome, said liposome externally comprising a negatively charged scavenger receptor ligand. The invention further encompasses a method of treating a lysosomal storage disease with the compositions listed above. The invention further encompasses a method of treating a lysosomal storage disease with an acylated, acetylated, or aconitylated lysosomal enzyme. 1. A composition comprising a lysosomal enzyme conjugated to a negatively charged scavenger receptor ligand.2. The composition of claim 1 , wherein said lysosomal enzyme is selected from the group consisting of α-galactosidase A claim 1 , α-sialidase claim 1 , α-mannosidase claim 1 , β-mannosidase claim 1 , glycosylasparaginase claim 1 , α-fucosidase claim 1 ,α-N-acetylglucosaminidase claim 1 , β-galactosidase claim 1 , β-hexosaminidase claim 1 , α-subunit claim 1 , β-hexosaminidase β-subunit claim 1 , GM2 activator protein claim 1 , glucocerebrosidase claim 1 , saposin C claim 1 , arylsulfatase A claim 1 , saposin B claim 1 , formyl-glycin generating enzyme claim 1 , β-galactosylceramidase claim 1 , iduronate sulfatase claim 1 , α-iduronidase claim 1 , heparan N-sulfatase claim 1 , acetyl-CoA transferase claim 1 , N-acetyl glucosaminidase claim 1 , β-glucuronidase claim 1 , N-acetyl glucosamine 6-sulfatase claim 1 , N-acetylgalactosamine 4-sulfatase claim 1 , galactose 6-sulfatase claim 1 , hyaluronidase claim 1 , α-glucosidase claim 1 , acid sphingomyelinase claim 1 , acid ceramidase claim 1 , acid lipase claim 1 , cathepsin K claim 1 , cathepsin A claim 1 , tripeptidyl peptidase claim 1 , palmitoyl-protein thioesterase.3. The composition of claim 1 , wherein said ...

USE OF HSP70 AS A REGULATOR OF ENZYMATIC ACTIVITY

The present invention concerns a method for modulating the enzymatic activity of an enzyme, wherein said enzyme interacts with BMP, said method comprising the step of administering or inducing Hsp70, or a functional fragment or variant thereof, in a form suitable for allowing interaction between BMP and Hsp70, or said functional fragment or variant thereof, and thereby modulating the enzymatic activity of an enzyme interacting with BMP. 1. A method for treatment of a lysosomal storage disease comprising administration to an individual in need thereof a bioactive agent capable of increasing the intracellular concentration of Hsp70 by amplifying Hsp70 gene expression , wherein said bioactive agent is a hydroxylamine derivative.2. The method according to claim 1 , wherein said treatment is curative or ameliorating.3. The method according to claim 1 , wherein said treatment is administered prior to onset of the disease.4. The method according to claim 1 , wherein said bioactive agent is capable of amplifying Hsp70 gene expression with a concomitant stress.5. The method according to claim 1 , wherein said hydroxylamine derivative is bimoclomol claim 1 , or a structural analogue thereof.6. The method according to claim 1 , wherein said hydroxylamine derivative is selected from the group consisting of bimoclomol claim 1 , BRLP-42 claim 1 , arimoclomol claim 1 , BRX-220 claim 1 , BRX-345 and BGP-15.7. The method according to claim 1 , wherein said hydroxylamine derivative is arimoclomol.8. The method according to claim 1 , wherein said hydroxylamine derivative is BRX-345.9. The method according to claim 1 , wherein said lysosomal storage disease is selected from the group consisting of Niemann-Pick disease claim 1 , Farber disease claim 1 , Krabbe disease claim 1 , Fabry disease claim 1 , Gaucher disease claim 1 , Sialidosis claim 1 , Metachromatic leukodystrophy and saposin-deficiency.10. The method according to claim 9 , wherein said Niemann-Pick disease is selected from ...

PROTEIN HYDROLYSATES AS AGENTS FOR OVERCOMING ADDICTION

This invention is directed to the use of a protein hydrolysate, and in particular an egg lysozyme hydrolysate to assist an animal, including a human in overcoming an addition, or by breaking an unwanted habit. 1. Use of a hydrolyzed lysozyme composition to assist an animal , including a human , in refraining from engaging in an undesired behavior , and/or refraining from indulging in an addictive behavior and/or reward-seeking behavior.2. Use according to wherein the animal is a human.3. Use according to wherein the animal is an animal in a zoo claim 1 , a farm animal claim 1 , a pet or companion animal claim 1 , or a racing animal.4. Use according to wherein the behavior is selected from the group consisting of: smoking claim 1 , alcohol abuse claim 1 , gambling claim 1 , drug abuse claim 1 , compulsive behaviors claim 1 , uncontrollable behaviors such as compulsive shopping claim 1 , eating claim 1 , hoarding claim 1 , improper sexual behaviors claim 1 , kleptomania claim 1 , pyromania claim 1 , cutting or self harm claim 1 , cravings claim 1 , and potentially harmful risky behaviors.5. Use according to wherein the behavior is a habit which the individual wishes to break.6. Use according to wherein the hydrolyzed lysozyme composition is present in a food claim 1 , feed claim 1 , nutraceutical claim 1 , or food supplement.7. Use according to as an adjunctive treatment or supportive accompanying diet during dehabituation programs claim 1 , or to assist dehabituation processes.8. Use according to wherein the hydrolyzed lysozyme composition is characterized by: a Trp/LNAA ratio between 0.15 and 0.20.9. A method of assisting an animal claim 1 , including a human claim 1 , in refraining from an undesired behavior claim 1 , and/or resisting from indulging in an addictive behavior comprising:a) administering a hydrolyzed lysozyme composition, and b) noticing abstinence from the behavior.10. A method according to wherein the animal is a human.11. A method according to ...

Targeted therapeutic proteins

Targeted therapeutics that localize to a specific subcellular compartment such as the lysosome are provided. The targeted therapeutics include a therapeutic agent and a targeting moiety that binds a receptor on an exterior surface of the cell, permitting proper subcellular localization of the targeted therapeutic upon internalization of the receptor. Nucleic acids, cells, and methods relating to the practice of the invention are also provided.

TREATMENT FOR IgE-MEDIATED DISEASE

The invention provides an EndoS polypeptide, or a polynucleotide encoding an EndoS polypeptide, for use in a method for treating or preventing a disease or condition mediated by IgE antibodies. 19-. (canceled)10. A method of treating a disease or condition mediated by IgE antibodies in a subject , the method comprising administering to the subject a therapeutically effective amount of an EndoS polypeptide , or a polynucleotide encoding an EndoS polypeptide.11. A method of treating , ex vivo , blood taken from a patient suffering from a disease or condition mediated by IgE antibodies , comprising contacting the blood with an EndoS polypeptide.12. The method of claim 11 , wherein the blood is returned to the patient after the step of contacting.13. A method of screening for a test polypeptide having one or more effects selected from:{'sub': 'D', '(i) greater affinity (lower K) for IgE compared to the affinity for IgE of an EndoS polypeptide that consists of the amino acid sequence set forth in SEQ ID NO:1,'}(ii) greater IgE endoglycosidase activity compared to the IgE endoglycosidase activity of an EndoS polypeptide that consists of the amino acid sequence set forth in SEQ ID NO:1,(iii) greater ability to remove IgE from at least one of a basophil surface and a mast cell surface compared to the IgE-removing ability of an EndoS polypeptide that consists of the amino acid sequence set forth in SEQ ID NO:1, and(iv) greater ability to reduce activity of IgE in vivo compared to in vivo IgE activity-reducing ability of an EndoS polypeptide that consists of the amino acid sequence set forth in SEQ ID NO:1,said method comprising:(a) assessing the test polypeptide for one or more of the effects of (i) to (iv) to obtain one or more test polypeptide results; and(b) comparing the one or more test polypeptide results obtained in step (a) to results obtained when assessing the EndoS polypeptide consisting of the amino acid sequence of SEQ ID NO: 1, and thereby screening for said ...

STREPTOCOCCUS BACTERIOPHAGE LYSINS FOR DETECTION AND TREATMENT OF GRAM POSITIVE BACTERIA

The present invention provides methods, compositions and articles of manufacture useful for the prophylactic and therapeutic amelioration and treatment of gram-positive bacteria, including and , and related conditions. The invention provides compositions and methods incorporating and utilizing derived bacteriophage lysins, particularly PlySs2 and/or PlySs1 lytic enzymes and variants thereof, including truncations thereof. Methods for treatment of humans are provided. 1. A pharmaceutical composition for killing gram-positive bacteria comprising the isolated lysin polypeptide comprising the amino acid sequence of SEQ ID NO:3 or variants thereof having at least 80% identity to the polypeptide of SEQ ID NO:3 and effective to kill the gram-positive bacteria.2. The composition of further comprising an effective amount of the isolated lysin polypeptide comprising the amino acid sequence of SEQ ID NO:1 claim 1 , the isolated lysin polypeptide comprising the amino acid sequence of SEQ ID NO:2 claim 1 , or variants thereof having at least 80% identity to the polypeptide of SEQ ID NO:1 or of SEQ ID NO:2 and effective to kill the gram-positive bacteria.3. (canceled)4. A pharmaceutical composition comprising a truncated lysin having the amino acid sequence of SEQ ID NO: 1 with a modification whereby the truncated lysin comprises only one catalytic domain selected from the group consisting of an endopeptidase domain and a glucosaminidase domain.5. The composition of wherein the truncated lysin does not include the glucosaminidase domain of SEQ ID NO:1.6. The composition of wherein the truncated lysin has the amino acid sequence of SEQ ID NO:2 claim 4 , or variants thereof having at least 80% identity to the polypeptide of SEQ ID NO:2 and effective to kill gram-positive bacteria.7Staphylococcus, StreptococcusListeria. An article of manufacture comprising a vessel containing the composition of and instructions for use of the composition in treatment of a patient exposed to or ...

Antibacterial Phage, Phage Peptides And Methods Of Use Thereof

The present invention is directed to the field of phage therapy for the treatment and control of bacterial infections. In particular, the present invention is directed to the novel bacteriophage F387/08, F391/08, F394/08, F488/08, F510/08, F44/10, and F125/10, isolated polypeptides thereof, compositions comprising one or more of the novel bacteriophage and/or isolated polypeptides, as well as to methods for the treatment and prevention of bacterial infections using same, either alone or in combination with other antibacterial therapies, e.g., antibiotics and/or other phage therapies. 1. An isolated bacteriophage having a genome which comprises the nucleic acid sequence of SEQ ID NO: 1 , SEQ ID NO:2 , SEQ ID NO:3 , SEQ ID NO:4 , SEQ ID NO.560 , SEQ ID NO:781 , or SEQ ID NO: 1074.216-. (canceled)17Klebsiella pneumoniae, Acinetobacter baumannii, Escherichia coli, Pseudomonas aeruginosaStaphylococcus aureus. An isolated protein from bacteriophage F387/08 , F391/08 , F394/08 , F488/08 , F510/08 , F44/10 , or 125/10 , or a fragment , variant or derivative thereof having antibacterial or antimicrobial activity against one or more of , and or having a biological activity associated with the bacteriophage from which it was isolated , wherein said protein is a lysin protein or a tail protein.18. (canceled)19. An isolated first protein having at least 85% or at least 95% sequence identity to a second protein of the same size ,{'i': Klebsiella pneumoniae, Acinetobacter baumannii, Escherichia coli, Pseudomonas aeruginosa', 'Staphylococcus aureus, 'wherein said first protein has antibacterial or antimicrobial activity against , and/or and said second protein has the amino acid sequence of SEQ ID NO: 20, SEQ ID NO: 80, SEQ ID NO: 192, SEQ ID NO: 282, SEQ ID NO: 547, SEQ ID NO: 556, SEQ ID NO: 557, SEQ ID NO: 598, SEQ ID NO: 1216, or SEQ ID NO: 1261, or a fragment thereof: or'}wherein said first protein has a biological activity associated with bacteriophage F387/08, F391/08, F394/ ...

NEW ENDOLYSIN PLYP40

The present invention relates to a polypeptide with an amino acid sequence according to SEQ ID NO:1. The present invention further relates to the nucleic acid molecules comprising a nucleotide sequence coding for the polypeptide, vectors comprising the nucleic acid molecules, and host cells for the expression of the polypeptides. In addition, the present invention relates to the use of the polypeptide as a human medical, veterinary medical or diagnostic substance, as an antimicrobial substance in food, in cosmetics, as disinfecting agent or in the environmental field. 1. A polypeptide comprising an amino acid sequence according to SEQ ID NO:1 or a variant thereof.2. The polypeptide according to claim 1 , wherein the variant has a deletion claim 1 , addition claim 1 , insertion and/or substitution in the amino acid sequence according to SEQ ID NO:1.3. A nucleic acid molecule comprising a nucleotide sequence coding a polypeptide according to .4. A vector comprising a nucleic acid molecule according to .5. A host cell comprising a nucleic acid molecule according to .6listerialisteria. A method for the detection of contamination in a food comprising (a) contacting a polypeptide comprising an amino acid sequence according to SEQ ID NO:1 or a variant thereof with said food; and (b) detecting binding of said polypeptide to in said food.7. The method according to claim 6 , wherein the food comprises a dairy product claim 6 , a smoked fish claim 6 , a salted fish claim 6 , frozen seafood claim 6 , a meat product claim 6 , a salad or a convenience product.8listeria. A method for therapy and/or prevention of disease caused by comprising administering to a subject in need thereof a polypeptide comprising the amino acid sequence according to SEQ ID NO:1 or a variant thereof.9listeria. The method according to claim 8 , wherein the disease caused by comprises listeriosis claim 8 , gastroenteritis claim 8 , meningitis claim 8 , encephalitis claim 8 , sepsis claim 8 , local wound ...

Novel Compositions for Preventing and/or Treating Lysosomal Storage Disorders

The present invention provides novel compositions as well as methods for preventing and/or treating lysosomal storage disorders. In particular, the present invention provides methods for preventing and/or treating Gaucher's disease. 120-. (canceled)29. The method of claim 21 , further comprising administering an effective amount of at least one other therapeutic agent.30. The method of claim 21 , wherein the lysosomal storage disease is Niemann-Pick disease.31. The method of claim 21 , wherein the lysosomal storage disease is Gaucher's disease.32. The method of claim 23 , further comprising administering an effective amount of at least one other therapeutic agent.33. The method of claim 32 , wherein at least one other therapeutic agent is imiglucerase or 1 claim 32 ,5-(butylimino)-1 claim 32 ,5-dideoxy-D-glucitol.35. The method of claim 34 , further comprising administering an effective amount of at least one other therapeutic agent.36. The method of claim 35 , wherein at least one other therapeutic agent is imiglucerase or 1 claim 35 ,5-(butylimino)-1 claim 35 ,5-dideoxy-D-glucitol.38. The kit of claim 37 , wherein the lysosomal storage disorder is Gaucher's disease. The present invention provides novel compounds, known as pharmacological chaperones, as well as methods using the same for preventing and/or treating lysosomal storage disorders. In particular, the present invention provides methods for preventing and/or treating Gaucher's disease.Lysosomal storage disorders are caused by a defect in lysosomal function that results in accumulation of substances within the lysosome of cells. This defect is usually a consequence of deficiency of a single enzyme required for the metabolism of lipid, glycogen, glycoprotein, or mucopolysaccharide. Gaucher's disease, the most common lysosomal storage disorder, is characterized by accumulation of the glycolipid glucocerebroside (also known as glucosylceramide). Symptoms of Gaucher's disease include enlarged spleen and liver, ...

Novel modulators and methods of use

Novel modulators, including antibodies and derivatives thereof, and methods of such modulators to treat hyperproliferative disorders are provided.

Microparticle Formulations for Delivery to the Lower and Central Respiratory Tract and Methods of Manufacture

Microparticle formulations of a sialidase fusion protein are produced by contacting an aqueous solution of a protein or other active agent with an organic solvent, a counterion and a scavenging agent, and chilling the solution. The microparticles are useful for preparing stable, uniform pharmaceuticals of predetermined defined dimensions. 1. A method of making a composition comprising microparticles comprising DAS181 , the method comprising:a) providing a feedstock composition comprising DAS181, a counterion and an organic solvent; andb) cooling the composition to below 25° C., whereby a composition comprising microparticles comprising DAS181 is formed.2. The method of wherein the DAS181 comprises a polypeptide comprising the amino acid sequence of SEQ ID NO:1.3. The method of wherein the DAS181 comprises a polypeptide comprising the amino acid sequence of SEQ ID NO:2.413.-. (canceled)14. The method of wherein the step of providing a feedstock composition containing DAS181 claim 1 , a counterion and an organic solvent at a temperature at or above about 25° C. comprises providing a solution containing DAS181 and a counterion in an aqueous solvent and adding an organic solvent to the solution containing DAS181 and a counterion in an aqueous solvent.15. The method of claim 1 , further comprising isolating the microparticles from the composition comprising microparticles claim 1 , whereby a dry powder formulation of microparticles is formed.16. (canceled)17. The method of claim 1 , wherein the feedstock composition comprises two or more counterions.1836.-. (canceled)37. The method of any of the forgoing claims claim 1 , further comprising adding a scavenging agent to the mixture comprising the active agent claim 1 , the counterion and the organic solvent or to the solution comprising the active agent and the counterion.38. The method of claim 37 , wherein the scavenging agent is selected from among an amine claim 37 , an antioxidant claim 37 , a sugar claim 37 , a ...

ANTI-PATHOGENIC ACTIVITY OF A BIFUNCTIONAL PEPTIDOGLYCAN/CHITIN HYDROLASE

The present invention generally relates to the use of a bifunctional peptidoglycan/chitin hydrolase to reduce and/or prevent hyphae formation in a pathogen, and/or to reduce or prevent biofilm formation. The present invention further relates to a bifunctional peptidoglycan/chitin hydrolase for use in the treatment and/or prevention of pathogenic infections, in particular yeast or bacterial infections. In another aspect, the present invention provides the use of a bifunctional peptidoglycan/chitin hydrolase as a anti-pathogenic agent in non-medical applications; in particular in the personal hygiene industry, food industry, cleaning industry, pharma industry, or biocontrol and crop protection industry. 122-. (canceled)23. A method of reducing and/or preventing hyphae formation in a pathogen , the method comprising contacting the pathogen with a bifunctional peptidoglycan/chitin hydrolase.24. The method according to claim 23 , wherein the bifunctional peptidoglycan/chitin hydrolase is present in a composition.25. The method according to claim 23 , wherein the bifunctional peptidoglycan/chitin hydrolase is major secreted protein 1 (Msp1).26. The method according to claim 23 , wherein the bifunctional peptidoglycan/chitin hydrolase comprises at least 70% sequence homology to SEQ ID NO: 1.27. The method according to claim 23 , wherein the bifunctional peptidoglycan/chitin hydrolase comprises at least 70% sequence homology to SEQ ID NO: 3.28LactobacillusLactobacillus rhamnosus, Lactobacillus casei, Lactobacillus paracaseiLactobacillus fermentum.. The method according to claim 23 , wherein the bifunctional peptidoglycan/chitin hydrolase is obtained from a strain selected from the group consisting of claim 23 , and29. The method according to claim 23 , wherein the pathogen is selected from a yeast or a bacterium.30. The method according to claim 24 , wherein the composition has a pH lower than 7.31. The method according to claim 24 , wherein the composition further ...

Polypeptides Having N-Acetyl Glucosamine Oxidase Activity

The present invention relates to polypeptides having N-acetyl glucosamine oxidase activity and polynucleotides encoding the polypeptides. The invention also relates to nucleic acid constructs, vectors, and host cells comprising the polynucleotides as well as methods of producing and using the polypeptides. 115-. (canceled)16. A polypeptide having N-acetyl-D-glucosamine oxidase activity , selected from the group consisting of:(a) a polypeptide having at least 75% sequence identity to the mature polypeptide of SEQ ID NO: 2;(b) a polypeptide encoded by a polynucleotide that hybridizes under high stringency conditions with (i) the mature polypeptide coding sequence of SEQ ID NO: 1, (ii) the cDNA sequence thereof, or (iii) the full-length complement of (i) or (ii);(c) a polypeptide encoded by a polynucleotide having at least 75% sequence identity to the mature polypeptide coding sequence of SEQ ID NO: 1 or the cDNA sequence thereof; and(d) a fragment of the polypeptide of (a), (b), or (c) that has N-acetyl-D-glucosamine oxidase activity.17. The polypeptide of claim 16 , comprising or consisting of SEQ ID NO: 2 or the mature polypeptide of SEQ ID NO: 2.18. The polypeptide of claim 16 , wherein the mature polypeptide is amino acids 20 to 632 of SEQ ID NO: 2.19. The polypeptide of claim 16 , which has at least 20% of the antimicrobial activity of the mature polypeptide of SEQ ID NO: 2.20. The polypeptide of claim 19 , wherein the antimicrobial activity is assessed using a method described in Example 6 claim 19 , 7 claim 19 , 8 claim 19 , or 9.21Aspergillus carbonariusAspergillus niger. The polypeptide of claim 19 , wherein the antimicrobial activity is assessed as fungicidal or sporicidal effect towards any of the fungal strains BR00732 (CBS 139193) and strain BR00883 (accession number CBS 139194).22. A cleaning composition consisting of the polypeptide of and one or more ingredients used in cleaning compositions claim 16 , such as a surfactant.22. A method of cleaning and/ ...

Use of direct- fed microbials in preventing and/or treating e. coli-based infections in animals

A composition and method for preventing and/or treating an E. coli-based infection in an animal is described.

Compositions and methods for treating mpsi

A vector having an expression cassette having a hIDUA gene having a sequence of SEQ ID NO: 1 or a sequence at least about 95% identical thereto which encodes a functional human alpha-L-iduronidase is provided. The vector may be production vector or a rAAV8. Also provided are compositions containing these vectors and methods of treating MPSI and the symptoms associated with Hurler, Hurle-Scheie and Scheie syndromes.

COMPOSITIONS AND METHODS FOR TREATING PARKINSON'S DISEASE

Described herein are methods for treating a subject having or at risk of developing Parkinson's disease, by administering pluripotent cells that express glucocerebrosidase (GBA) or pluripotent cells that express GBA and one or more M2-promoting agents to the subject. Also disclosed are compositions comprising pluripotent cells expressing GBA, such as pluripotent cells expressing GBA and one or more M2-promoting agents. 1. A method of treating Parkinson's disease in a subject , the method comprising administering to the subject a composition comprising a population of pluripotent cells that express a transgene encoding glucocerebrosidase (GBA).2. The method of claim 1 , wherein the GBA is full-length GBA.3. The method of claim 1 , wherein the GBA is a catalytic domain of GBA.4. The method of any one of - claim 1 , wherein the GBA has an amino acid sequence that is at least 85% identical to the amino acid sequence of SEQ ID NO. 1.5. The method of claim 4 , wherein the GBA has an amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO. 1.6. The method of claim 5 , wherein the GBA has an amino acid sequence that is at least 95% identical to the amino acid sequence of SEQ ID NO. 1.7. The method of claim 6 , wherein the GBA has an amino acid sequence that is at least 95% identical to the amino acid sequence of SEQ ID NO. 1.8. The method of any one of - claim 6 , wherein the GBA has an amino acid sequence that is at least 85% identical to the amino acid sequence of SEQ ID NO. 5.9. The method of claim 8 , wherein the GBA has an amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO. 5.10. The method of claim 9 , wherein the GBA has an amino acid sequence that is at least 95% identical to the amino acid sequence of SEQ ID NO. 5.11. The method of claim 10 , wherein the GBA has the amino acid sequence of SEQ ID NO. 5.12. The method of any one of - claim 10 , wherein the transgene encoding GBA has a nucleic ...

COMPOSITIONS AND METHODS TO PREVENT AND TREAT BIOFILMS

Compositions and methods to treat biofilms are disclosed based on the discovery of the role of the disaccharide trehalose in microbial biofilm development. In various embodiments to treat body-borne biofilms systemically and locally, the method includes administering trehalase, the enzyme which degrades trehalose, in combination with other saccharidases for an exposition time sufficient to adequately degrade the biofilm gel matrix at the site of the biofilm. The method also includes administering a combination of other enzymes such as proteolytic, fibrinolytic, and lipolytic enzymes to break down proteins and lipids present in the biofilm, and administering antimicrobials for the specific type(s) of infectious pathogen(s) underlying the biofilm. Additionally, methods are disclosed to address degradation of biofilms on medical device surfaces and biofilms present in industrial settings. 1Staphylococcus aureus{'i': 'S. aureus', 'providing a catheter that has no biofilm growth resulting from bacteria on the catheter; and'}{'i': 'S. aureus', 'adding onto the catheter a composition as a solution comprising trehalase, wherein the trehalase comprises about 0.05%-5% by weight of the composition and the trehalase is derived from a mammalian or plant source wherein biofilm mass and biofilm cell growth by on the catheter is reduced.'}. A method of reducing growth of biofilm mass and biofilm cells on a catheter resulting from bacteria, comprising: This is continuation application of Ser. No. 15/632,618 filed Jun. 26, 2017, which is a continuation-in-part application of Ser. No. 13/481,787 filed May 26, 2012, which is based on provisional application Ser. No. 61/520,654 filed Jun. 13, 2011, the disclosures which are hereby incorporated by reference in their entirety.The present disclosure is generally related to compositions and methods to prevent and treat biofilms.Over the last century, bacterial biofilms have been described as a ubiquitous form of microbial life in various ...

PREBIOTIC OLIGOSACCHARIDES

The present invention provides galacto-oligosaccharide compositions that preferentially stimulate growth of specific species and subspecies. 1Bifidobacterium. A method for stimulating beneficial microflora in an animal , the method comprising ,{'i': 'Bifidobacterium', 'administering a sufficient amount of the composition of galacto-oligosaccharides, wherein at least 45% of the galacto-oligosaccharides by weight are tetra or penta galacto-oligosaccharides or wherein at least 25% of the galacto-oligosaccharides by weight are tetra galacto-oligosaccharides, to the animal to stimulate colonization of the gut of the animal by at least one beneficial strain.'}2Bifidobacterium breveBifidobacterium longuminfantis.. The method of claim 1 , wherein the composition further comprises or bv.3. The method of claim 1 , wherein the composition has less than 20% by weight of dimeric galacto-oligosaccharides claim 1 , based on weight of the total oligosaccharides.4. The method of claim 1 , wherein the composition has less than 10% by weight of dimeric galacto-oligosaccharides claim 1 , based on weight of the total oligosaccharides.5. The method of claim 1 , wherein the composition has less than 5% by weight of monomeric sugars based on total sugar and oligosaccharide solids.6. The method of claim 1 , wherein the composition has less than 5% by weight of lactose claim 1 , based on weight of the total oligosaccharides.7. The method of claim 1 , wherein the composition comprises a lactase enzyme.8. The method of claim 1 , wherein the composition is a food product or dietary supplement product.9. The method of claim 1 , wherein the food product is selected from the group consisting of an infant formula claim 1 , a follow-on formula claim 1 , and a toddler beverage.10. The method of claim 1 , wherein less than 10% of the galacto-oligosaccharides by weight have a degree of polymerization of 6 or greater.11. The method of claim 1 , wherein less than 10% of the galacto-oligosaccharides by ...

Compositions for Relieving the Symptoms of Gluten Sensitivity and Methods of Use Thereof

The disclosure relates to a composition that may be used to prevent the symptoms of non-celiac gluten sensitivity and may include ingredients that degrade or inactivate gluten and other components that may cause these symptoms. 1. A composition for reducing gluten sensitivity , comprising at least three proteases;at least one carbohydrase;at least one probiotic; andwherein said composition relieves symptoms of gluten sensitivity.2. The composition of further comprising ginger and turmeric.3. The composition of wherein said composition relieves the symptoms of non-celiac gluten sensitivity.4Aspergillus oryzaeAspergillus melleus. The composition of wherein said at least three proteases are selected from the group consisting of Protease 3.0 claim 1 , Protease 4.5 claim 1 , Protease 6.0 claim 1 , Papain claim 1 , Bromelain claim 1 , Protease claim 1 , Protease claim 1 , Proteases I-V claim 1 , and DPP IV and combinations thereof.5. The composition of wherein said at least one carbohydrase is selected from the group consisting of lactase claim 1 , α-galactosidase claim 1 , β-glucanase claim 1 , xylanase claim 1 , glucoamylase claim 1 , amylase claim 1 , hemicellulase claim 1 , invertase and pectinase and combinations thereof.6Lactococcus lactisLactococcus cremoris.. The composition of wherein said at least one probiotic is selected from the group consisting of and7. The composition of wherein said composition prevents the symptoms of non-celiac gluten sensitivity where said symptoms are selected from the group consisting of abdominal pain claim 1 , cramping claim 1 , bloating/distention claim 1 , diarrhea claim 1 , constipation and fatigue and combinations thereof.8. The composition of wherein said symptoms of non-celiac gluten sensitivity are selected from the group consisting of abdominal pain claim 7 , bloating claim 7 , changes in bowel habits and fatigue and combinations thereof.9. The composition of wherein said composition reduces the concentration of gluten to ...

ULTRAPURE HYPOALLERGENIC SOLUTIONS OF SACROSIDASE

One aspect provides an ultrapure, hypoallergenic sacrosidase. Another aspect provides a solution of sacrosidase in about 1:1 glycerol/water having an enzymatic activity of at least about 7500 IU/mL and a residual papain concentration that does not include an allergic reaction in a human patient when given a dose of about 2.0 mL/day. 1. A protein composition consisting essentially of sacrosidase having a band volume ratio of sacrosidase to other proteins comprising papain of at least about 35:1 by SDS-PAGE of about 20 μg of said composition , wherein the primary structure of the sacrosidase is a 513 amino acid polypeptide that is glycosylated.25. The protein composition of claim , wherein the band volume ratio is about 35-55:1.35. The protein composition of claim that is not produced by chromatographic purification of the sacrosidase. This application is a continuation and claims the benefit of priority of U.S. patent application Ser. No. 14/828,006, filed on Aug. 17, 2015 which claims the benefit of priority of U.S. patent application Ser. No. 14/175,263, filed on Feb. 7, 2014, which is incorporated by reference herein in its entirety.Congenital sucrose-isomaltase deficiency (CSID) is a chronic, autosomal recessive, inherited, phenotypically heterogenous disease with variable enzyme activity. CSID is usually characterized by a subject having complete or almost complete lack of endogenous human sucrase activity, along with a very marked reduction in isomaltase activity, a moderate decrease in maltase activity, and the subject can have normal or abnormal lactase levels.The human enzyme sucrase-isomaltase is naturally produced in the brush border of the small intestine, primarily the distal duodenum and jejunum. The natural human enzyme hydrolyzes the disaccharide sucrose into its component monosaccharides, glucose and fructose. Isomaltase breaks down disaccharides from starch into simple sugars.In the absence of endogenous human sucrase-isomaltase enzyme, as in CSID, ...

Therapeutic agent for disc herniation

The present invention provides a therapeutic agent for disc herniation, which has extremely few adverse side effects, can achieve a prolonged pain-ameliorating effect when administered in only a single dose, and can exhibit a high therapeutic effect and high safety in clinical applications. The present invention relates to a therapeutic agent for disc herniation, which is characterized by containing chondroitinase ABC as an active ingredient and being administered in such a manner that the ingredient can be administered into a human disk in an amount of 1-8 units per disk.

DIETARY SUPPLEMENTS AND FORMULATIONS

Provided are dietary supplements, formulations, kits and methods for administration to an individual with type II diabetes or at risk of developing type II diabetes. Provided herein are formulations, kits and methods useful for treating, preventing, supporting, controlling, restoring, and/or maintaining blood sugar levels in individuals with type II diabetes or at risk of developing the same. Also provided are formulations, kits and methods useful for reducing and/or eliminating requirement of ex-vivo insulin administration in an individual diagnosed with type II diabetes. 1. A dietary supplement in a form selected from the group consisting of a tablet , capsule , pill , emulsion , ointment , lotion , suppository , and aerosol , the dietary supplement consisting essentially of:{'i': 'Cornus officinalis', 'at least one component selected from the group consisting of maca, fruit extract, and a combination thereof;'}{'i': 'Gymnema sylvestre', 'at least one component selected from the group consisting of berberine, bitter melon extract, leaf extract, banaba, carnitine, and combinations thereof;'}{'i': Panax ginseng', 'Rhodiola rosea', 'Eleutherococcus senticosus, 'at least one component selected from the group consisting of vitamin C, root extract, Aswagandha root extract, holy basil leaf extract, extract, extract, vitamin B5, cactus stem extract, phosphatidylserine, vitamin D, and combinations thereof;'}{'i': Cordyceps sinesis', 'Gingko biloba', 'Garcinia cambogia', 'Rehmannia glutinosa', 'Poria cocos', 'oblonga', 'stevia, 'at least one component selected from the group consisting of extract, leaf extract, suma root, extract, extract, root extract, cinnamon extract, Fenugreek, Guggul, citrimax extract, salacia extract, vitamin E, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, magnesium, zinc, selenium, manganese, chromium, vanadium, zinc, calcium, alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartrate, glutamine, ...

DIETARY SUPPLEMENTS AND FORMULATIONS

Provided are dietary supplements, formulations, kits and methods for administration to an individual with type II diabetes or at risk of developing type II diabetes. Provided herein are formulations, kits and methods useful for treating, preventing, supporting, controlling, restoring, and/or maintaining blood sugar levels in individuals with type II diabetes or at risk of developing the same. Also provided are formulations, kits and methods useful for reducing and/or eliminating requirement of ex-vivo insulin administration in an individual diagnosed with type II diabetes. 1. A dietary supplement in a form selected from the group consisting of a tablet , capsule , pill , emulsion , ointment , lotion , suppository , and aerosol , the dietary supplement consisting essentially of:cactus stem extract;{'i': 'Gymnema sylvestre', 'at least one component selected from the group consisting of berberine, bitter melon extract, leaf extract, banaba, carnitine, and combinations thereof;'}{'i': Garcinia cambogia', 'Rehmannia glutinosa', 'Poria cocos, 'at least one component selected from the group consisting of extract, extract, root extract, cinnamon extract, Fenugreek, Guggul, and combinations thereof;'}{'i': 'stevia', 'at least one component selected from the group consisting of vitamin D, vitamin E, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, vitamin B5, magnesium, zinc, selenium, manganese, chromium, vanadium, alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartarate, citrimax extract, taurine, coenzyme Q10, calcium, vitamin K2, vitamin C, protein, fiber, inositol, molybdenum, luo han guo, extract rebaudioside, and combinations thereof; and'}an excipient.2. The dietary supplement of claim 1 , wherein the excipient is selected from the group consisting of gelatin claim 1 , cellulose claim 1 , medium-chain triglyceride (MCT) oil claim 1 , silicon dioxide claim 1 , stearic acid claim 1 , and combinations thereof.3. The ...

Polynucleotides encoding alpha-galactosidase a for the treatment of fabry disease

The invention relates to mRNA therapy for the treatment of Fabry disease. mRNAs for use in the invention, when administered in vivo, encode human the α-galactosidase A (GLA), isoforms thereof, functional fragments thereof, and fusion proteins comprising GLA. mRNAs of the invention are preferably encapsulated in lipid nanoparticles (LNPs) to effect efficient delivery to cells and/or tissues in subjects, when administered thereto. mRNA therapies of the invention increase and/or restore deficient levels of GLA expression and/or activity in subjects. mRNA therapies of the invention further decrease levels of toxic metabolites associated with deficient GLA activity in subjects, namely Gb3 and lyso-Gb3.

POLYNUCLEOTIDES ENCODING ALPHA-GALACTOSIDASE A FOR THE TREATMENT OF FABRY DISEASE

The invention relates to mRNA therapy for the treatment of Fabry disease. mRNAs for use in the invention, when administered in vivo, encode human the α-galactosidase A (GLA), isoforms thereof, functional fragments thereof, and fusion proteins comprising GLA. mRNAs of the invention are preferably encapsulated in lipid nanoparticles (LNPs) to effect efficient delivery to cells and/or tissues in subjects, when administered thereto. mRNA therapies of the invention increase and/or restore deficient levels of GLA expression and/or activity in subjects. mRNA therapies of the invention further decrease levels of toxic metabolites associated with deficient GLA activity in subjects, namely Gb3 and lyso-Gb3. 1161.-. (canceled)163. The lipid nanoparticle of claim 162 , wherein the ORF is at least 80% identical to the nucleotide sequence of SEQ ID NO: 79.164. The lipid nanoparticle of claim 162 , wherein the ORF is at least 85% identical to the nucleotide sequence of SEQ ID NO: 79.165. The lipid nanoparticle of claim 162 , wherein the ORF is at least 90% identical to the nucleotide sequence of SEQ ID NO: 79.166. The lipid nanoparticle of claim 162 , wherein the ORF is at least 95% identical to the nucleotide sequence of SEQ ID NO: 79.167. The lipid nanoparticle of claim 162 , wherein the ORF is at least 98% identical to the nucleotide sequence of SEQ ID NO: 79.168. The lipid nanoparticle of claim 162 , wherein the ORF is at least 99% identical to the nucleotide sequence of SEQ ID NO: 79.169. The lipid nanoparticle of claim 162 , wherein the ORF is 100% identical to the nucleotide sequence of SEQ ID NO: 79.170. The lipid nanoparticle of claim 163 , wherein the 5′ UTR is at least 80% identical to the nucleotide sequence of SEQ ID NO: 33.171. The lipid nanoparticle of claim 163 , wherein the 3′ UTR comprises the nucleotide sequence of SEQ ID NO: 162.172. The lipid nanoparticle of claim 163 , wherein the 5′ terminal cap is Cap1.173. The lipid nanoparticle of claim 163 , wherein the ...

SUBSTITUTED QUINAZOLINE COMPOUNDS AND USES THEREOF FOR MODULATING GLUCOCEREBROSIDASE ACTIVITY

Disclosed are new small molecules having a substituted quinazoline core structure and the uses thereof for modulating glucocerebrosidase activity. Also disclosed are pharmaceutical compositions comprising the small molecules or activated glucocerebrosidase conjugated to the small molecules, which compositions may be administered in methods of treating diseases or disorders associated with glucocerebrosidase activity, including neurological diseases and disorders such as Gaucher's disease and Parkinson's disease. 2. The compound of wherein Ris H and n is 0.3. The compound of wherein Ris methyl and n is 04. The compound of wherein Ris H and n is 1.5. The compound of wherein Ris methyl and n is 1.6. The compound of wherein Ris a saturated or unsaturated homocycle or heterocycle comprising one 5- or 6-membered ring claim 1 , or a saturated or unsaturated homocycle or heterocycle comprising two or three fused 5- or 6-membered rings claim 1 , and Roptionally is substituted at one or more positions with a C1-C8 alkyl group claim 1 , a C1-C8 alkoxy group claim 1 , a halo group claim 1 , a phenyl group claim 1 , a benzyl group claim 1 , a tert-butyloxycarbonyl (BOC) group claim 1 , a sulfonylmethylphenyl group claim 1 , a 2 claim 1 ,3-dihydro-1 claim 1 ,4-benzodioxine-2-carbaldehyde group claim 1 , a 2 claim 1 ,3-dihydromethyl-1 claim 1 ,4-benzodioxin group claim 1 , an imidazole group claim 1 , a piperazine group claim 1 , a 1-methylpiperazine group claim 1 , a 4-piperazin-1-yl-benzaldehyde group claim 1 , a 4-(4-methylpiperazin-1-yl)benzaldehyde group claim 1 , or an azide group.9. The compound of wherein Rand Rtogether form a heterocycle comprising one 5- or 6-membered ring or two or three fused 5- or 6-membered rings.12. The compound of claim 1 , wherein Ris pyridinyl and Roptionally is substituted at one or more positions with C1-C8 alkyl claim 1 , halo claim 1 , amino claim 1 , amido.14. The compound of conjugated to biotin claim 1 , a solid support claim 1 , or a ...

Subcutaneous Formulations Of Anti-CD38 Antibodies And Their Uses

The present invention relates to subcutaneous formulations of anti-CD38 antibodies and their uses. 1. A pharmaceutical composition comprising about 1 ,800 mg of an anti-CD38 antibody and about 30 ,000 U of a hyaluronidase , wherein the anti-CD38 antibody is of an IgG1 isotype and comprises a heavy chain variable region sequence of SEQ ID NO: 4 and a light chain variable region sequence of SEQ ID NO: 5 , and wherein the hyaluronidase is rHuPH20 (SEQ ID NO: 22).2. The pharmaceutical composition of claim 1 , further comprising a pharmaceutically acceptable carrier.3. (canceled)4. (canceled)5. (canceled)6. (canceled)7. (canceled)8. (canceled)9. (canceled)10. (canceled)11. (canceled)12. (canceled)13. (canceled)14. The pharmaceutical composition of claim 2 , wherein the anti-CD38 antibody comprisesa heavy chain of SEQ ID NO: 12 and a light chain of SEQ ID NO: 13.15. (canceled)16. (canceled)17. (canceled)18. (canceled)19. (canceled)20. (canceled)21. (canceled)22. (canceled)23. (canceled)24. (canceled)25. The pharmaceutical composition of claim 2 , further comprisinga) from about 5 mM to about 50 mM histidine; andb) from about 50 mM to about 400 mM sorbitol.26. The pharmaceutical composition of claim 25 , further comprisinga) from about 0.01% w/v to about 0.1% polysorbate-20 (PS-20);b) from about 0.1 mg/mL to about 2.5 mg/mL methionine; orc) from about 0.01% w/v to about 0.1% PS-20 and from about 0.1 mg/mL to about 2.5 mg/mL methionine.27. (canceled)28. The pharmaceutical composition of claim 25 , comprisinga)a) about 10 mM histidine; andb) from about 100 mM to about 300 mM sorbitol.29. The pharmaceutical composition of claim 28 , further comprisinga) from about 0.01% w/v to about 0.04% w/v PS-20; andb) from about 1 mg/mL to about 2 mg/mL methionine.30. (canceled)31. The pharmaceutical composition of claim 26 , comprisinga)a) about 10 mM histidine;b) about 300 mM sorbitol;c) about 0.04% w/v PS-20; andd) about 1 mg/mL methionine; pH about 5.6.32. The pharmaceutical ...

STREPTOCOCCUS BACTERIOPHAGE LYSINS FOR DETECTION AND TREATMENT OF GRAM POSITIVE BACTERIA

The present invention provides methods, compositions and articles of manufacture useful for the prophylactic and therapeutic amelioration and treatment of gram-positive bacteria, including and , and related conditions. The invention provides compositions and methods incorporating and utilizing derived bacteriophage lysins, particularly PlySs2 and/or PlySs1 lytic enzymes and variants thereof, including truncations thereof. Methods for treatment of humans are provided. 143-. (canceled)44StaphylococcusStreptococcusStaphylococcusStreptococcus. A chimeric protein comprising the catalytic domain of the isolated lysin polypeptide comprising the amino acid sequence of SEQ ID NO:3 or variants thereof having at least 80 identity to the polypeptide of SEQ ID NO:3 and effective to kill and bacteria , said catalytic domain operably linked or covalently attached to a heterologous protein or polypeptide , wherein the chimeric protein is biologically active to kill and bacteria.45StaphylococcusStreptococcus. The chimeric protein of wherein the catalytic domain comprises SEQ ID NO:4 or variants thereof having at least 80% identity to the polypeptide of SEQ ID NO:4 and biologically active to kill and bacteria.46StaphylococcusStreptococcus. The chimeric protein of which is a chimeric lytic enzyme comprising the catalytic domain of the isolated lysin polypeptide comprising the amino acid sequence of SEQ ID NO:3 or variants thereof having at least 80% identity to the polypeptide of SEQ ID NO:3 and effective to kill and bacteria claim 44 , wherein said catalytic domain is operably linked to a binding domain of another lysin.47Staphylococcus. The chimeric protein of wherein the catalytic domain is operably linked to a binding domain of a -specific lysin.48Streptococcus. The chimeric protein of wherein the catalytic domain is operably linked to a binding domain of a -specific lysin.49StaphylococcusStreptococcus. The chimeric protein of wherein the chimeric protein is effective to kill or ...

Treatment of glycogen storage disease type ii

Methods of treating glycogen storage disease type II, by administering acid α-glucosidase, are described, as are compositions for use in treatment of glycogen storage disease type II.

mRNA FOR USE IN TREATMENT OF HUMAN GENETIC DISEASES

Compositions for modulating the expression of a protein in a target cell comprising at least one RNA molecule which comprises at least one modification conferring stability to the RNA, as well as related methods, are disclosed. 120-. (canceled)21. A method of in vivo protein expression , comprising administration of a composition comprising at least one mRNA molecule encoding a protein of interest and a 5′ untranslated region (UTR) comprising SEQ ID NO: 1 , wherein SEQ ID NO: 1 enhances the expression of the protein of interest.22. The method of claim 21 , wherein said mRNA molecule further comprises a poly A tail.23. The method of claim 21 , wherein said mRNA molecule further comprises a Cap1 structure.24. The method of claim 21 , wherein said mRNA molecule further comprises a 3′ untranslated region (UTR).25. The method of claim 24 , wherein said 3′ UTR comprises a sequence encoding human growth hormone (hGH).26. The method of claim 25 , wherein said sequence encoding human growth hormone (hGH) comprises SEQ ID NO: 3.27. The method of claim 21 , wherein the protein of interest is ornithine carbamoyltransferase.28. The method of claim 21 , wherein the protein of interest is alpha galactosidase.29. The method of claim 21 , wherein the protein of interest is erythropoietin.30. The method of claim 21 , wherein the protein is expressed in a target cell selected from hepatocytes claim 21 , epithelial cells claim 21 , hematopoietic cells claim 21 , endothelial cells claim 21 , lung cells claim 21 , bone cells claim 21 , stem cells claim 21 , mesenchymal cells claim 21 , neural cells claim 21 , cardiac cells claim 21 , adipocytes claim 21 , vascular smooth muscle cells claim 21 , cardiomyocytes claim 21 , skeletal muscle cells claim 21 , beta cells claim 21 , pituitary cells claim 21 , synovial lining cells claim 21 , ovarian cells claim 21 , testicular cells claim 21 , fibroblasts claim 21 , B cells claim 21 , T cells claim 21 , reticulocytes claim 21 , leukocytes claim ...

METHODS FOR TREATING SYMPTOMS AND DISORDERS ASSOCIATED WITH LYSOSOMAL STORAGE DISEASES

This disclosure to methods for treating or preventing particular symptoms and disorders which are associated with lysosomal storage diseases using quinuclidine compounds of formula (I), optionally in combination with enzyme replacement therapy. This includes supranuclear gaze palsies, including horizontal and vertical saccadic gaze palsies, and cognitive deficits or gait disorders, such as in a patient having Gaucher disease or Niemann-Pick disease Type C. Also disclosed is a pharmaceutical composition comprising a quinuclidine compound for use in said methods. 2. The method of claim 1 , wherein Ris selected from hydrogen claim 1 , fluorine claim 1 , methyl and ethyl claim 1 , wherein said methyl or ethyl is optionally substituted by 1 or 2 groups selected from halogen claim 1 , hydroxy claim 1 , thio or amino.3. The method of or claim 1 , wherein Rand Rare each independently selected from methyl and ethyl groups claim 1 , optionally substituted with one or more fluorines.4. The method of any one of to claim 1 , wherein Ris selected from a halogen (e.g. claim 1 , fluorine) claim 1 , C-alkyl (e.g. claim 1 , methyl) and C-alkyloxy (e.g. claim 1 , methoxy or ethoxy) claim 1 , wherein said alkyl or alkyoxy is optionally substituted by one or more (e.g. claim 1 , 1 claim 1 , 2 or 3) groups selected from a halogen and C-alkyloxy (e.g. claim 1 , methoxy or ethoxy).5. The method of any one of to claim 1 , wherein Rand Rare each hydrogen.6. The method of any one of to claim 1 , wherein Ris fluorine or 2-methoxyethoxy claim 1 , and Rand Rare hydrogen.7. The method of any one of to claim 1 , wherein Ris positioned at the 4-position of the phenyl ring to which it is attached (i.e. claim 1 , para to the A substituent).8. The method of any one of to claim 1 , wherein A is phenyl claim 1 , optionally substituted with 1 claim 1 , 2 or 3 groups independently selected from halogen claim 1 , hydroxy claim 1 , thio claim 1 , amino claim 1 , nitro claim 1 , Calkoxy and Calkyl (e.g. ...

FABRY DISEASE GENE THERAPY

There is described a nucleic acid molecule comprising a nucleotide sequence encoding for a functional α-galactosidase A protein wherein the nucleotide sequence has at least 85% identity to the sequence of SEQ ID NO. 1. Also described is a vector, host cell or transgenic animal comprising the nucleic acid molecule; and a pharmaceutical composition comprising the nucleic acid molecule or the vector. Further, the use of the nucleic acid molecule in a method of treating Fabry disease is described. 117-. (canceled)18. A method of administering a nucleic acid molecule to a subject , comprising administering to the subject the nucleic acid molecule comprising a nucleotide sequence encoding a polypeptide having α-galactosidase A activity , wherein the nucleotide sequence has at least 91% identity to the nucleotide sequence of SEQ ID NO: 1.191. The method of claim , wherein the subject suffers from Fabry disease.201. The method of claim , wherein the nucleotide sequence has at least 92% identity to the nucleotide sequence of SEQ ID NO: 1.211. The method of claim , wherein the nucleotide sequence has at least 93% identity to the nucleotide sequence of SEQ ID NO: 1.221. The method of claim , wherein the nucleotide sequence has at least 94% identity to the nucleotide sequence of SEQ ID NO: 1.231. The method of claim , wherein the nucleotide sequence has at least 95% identity to the nucleotide sequence of SEQ ID NO: 1.241. The method of claim , wherein the nucleotide sequence has at least 96% identity to the nucleotide sequence of SEQ ID NO: 1.251. The method of claim , wherein the nucleotide sequence has at least 97% identity to the nucleotide sequence of SEQ ID NO: 1.261. The method of claim , wherein the nucleotide sequence has at least 98% identity to the nucleotide sequence of SEQ ID NO: 1.271. The method of claim , wherein the nucleotide sequence has at least 99% identity to the nucleotide sequence of SEQ ID NO: 1.281. The method of claim , wherein the nucleotide sequence ...

Use of Bacterial Amylases in Feed for Poultry

The present invention relates to methods and uses of at least one bacterial amylase in poultry feed to improve the nutritional value of the feed. The invention also relates to poultry feed and poultry feed additives comprising at least one bacterial amylase and at least one vitamin and/or mineral which improve the nutritional value of the feed. 115-. (canceled)16. A method for improving the nutritional value of poultry feed , comprising adding at least one amylase to the feed , wherein the amylase is a polypeptide having at least 80% identity to amino acids 1-481 of SEQ ID NO: 2.17. The method of claim 16 , wherein the amylase has at least 85% identity to amino acids 1-481 of SEQ ID NO: 2.18. The method of claim 16 , wherein the amylase has at least 90% identity to amino acids 1-481 of SEQ ID NO: 2.19. The method of claim 16 , wherein the amylase has at least 95% identity to amino acids 1-481 of SEQ ID NO: 2.20. The method of claim 16 , wherein the amylase has at least 97% identity to amino acids 1-481 of SEQ ID NO: 2.21. The method of claim 16 , wherein the amylase comprises amino acids 1-481 of SEQ ID NO: 2.22. The method of claim 16 , wherein the poultry feed has reduced apparent metabolisable energy compared to a standard poultry feed.23. The method of claim 16 , wherein the amylase is added to the poultry feed at a dose of between 0.01 and 200 mg enzyme protein per kg diet.24. The method of claim 16 , for improving weight gain and/or feed conversion ratio of poultry.25. A poultry feed additive comprising at least one amylase claim 16 , together with (i) at least one vitamin claim 16 , (ii) at least one mineral claim 16 , or (iii) at least one vitamin and at least one mineral claim 16 , wherein the bacterial amylase is a polypeptide having at least 80% identity to amino acids 1-481 of SEQ ID NO: 2.26. The poultry feed additive of claim 25 , wherein the poultry feed additive improves the nutritional value of a poultry feed.27. The poultry feed additive of claim ...

A Method for Improving Maize Digestibility in Bovine Animals

The invention relates to the use of at least one bacterial amylase in combination with one or more protease(s) in feed for ruminant animals of the subfamily Bovinae for improving digestibility of maize and/or maize silages, in particular for improving milk yield, weight gain, and/or Feed Conversion Ratio (FCR). Examples of bovine animals are dairy cows and beef cattle. The invention also relates to the use of such enzyme combinations in feed additive compositions and animal feed compositions enriched with maize and maize silages. 111-. (canceled)12. A method for improving the digestibility of maize and/or maize silages in feed for animals of the subfamily Bovinae , comprising treating a maize source with an effective amount of one or more proteolytic enzymes in combination with at least one amylase.13. A method for increasing the milk yield , increasing the weight gain or improving the feed conversion ratio of an animal of the subfamily Bovinae , comprising adding at least one bacterial amylase and one or more proteolytic enzymes to the feed which comprises maize and/or maize silages.14. A feed composition comprising at least one bacterial amylase , one or more proteolytic enzymes , and maize and/or maize silage. High-yielding cows in modern farming systems live under conditions that are characterised by a very high milk production (dairy cows) or growth rate (beef cattle), which is followed by an equally high energy requirement. The utilisation of the feed decreases markedly when intake is increased beyond maintenance levels. In part to account for this, more and more easily degradable feed is included into the ruminant feed e.g. starch-containing raw materials such a cereal-based concentrates and whole cereal silages. The starchy material is frequently recovered in the faeces implying that the utilisation of such feed ingredients could be enhanced further.Maize or maize silage is becoming more common in increasing amounts in feed rations, in particular in feed for ...

Lysosomal Targeting Peptides and Uses Thereof

The present invention provides further improved compositions and methods for efficient lysosomal targeting based on the GILT technology. Among other things, the present invention provides methods and compositions for targeting lysosomal enzymes to lysosomes using furin-resistant lysosomal targeting peptides. The present invention also provides methods and compositions for targeting lysosomal enzymes to lysosomes using a lysosomal targeting peptide that has reduced or diminished binding affinity for the insulin receptor. 1. A method of treating Sanfilippo B disease (MPS IIIB) comprising administering to a subject in need of treatment a targeted therapeutic fusion protein comprising: a lysosomal enzyme which is α-N-Acetylglucosaminidase (Naglu); an IGF-II mutein comprising amino acids 8-67 of SEQ ID NO: 1 and an Ala substitution at position Arg37 of SEQ ID NO:1 , wherein the IGF-II mutein (i) has diminished binding affinity for the insulin receptor relative to the affinity of naturally-occurring human IGF-II for the insulin receptor , (ii) is resistant to furin cleavage and (iii) binds to the human cation-independent mannose-6-phosphate receptor in a mannose-6-phosphate-independent manner; and a spacer between the lysosomal enzyme and the IGF-II mutein , wherein the spacer comprises the amino acid sequence Gly-Ala-Pro.2. The method of claim 1 , wherein the IGF-II mutein is fused via the spacer to the C-terminus of the lysosomal enzyme.3. The method of claim 1 , wherein the IGF-II mutein is fused via the spacer to the N-terminus of the lysosomal enzyme.4. The method of claim 1 , wherein the IGF-II mutein consists of amino acids 8-67 of SEQ ID NO:1 having an Ala substitution at position Arg37 of SEQ ID NO:1.5. The method of claim 1 , comprising administering the targeted therapeutic fusion protein to the nervous system.6. The method of claim 5 , comprising administering the targeted therapeutic fusion protein intraventricularly and/or intrathecally.7. The method of ...

Use of CD83 in Combination Therapies

The present invention relates to improved methods of suppressing and/or preventing an undesired immune response comprising the use of CD83. In some embodiments, CD83 is coadministered to a subject with at least one other immunosuppressive compound. Methods are also provided for generating tolerogenic dendritic cells and regulatory T cells. These cells can be used in vitro to produce additional cells for therapeutic purposes or they can be used in vivo to suppress and/or prevent an undesired immune response. Methods of the invention can be used to prevent or reduce the severity of autoimmune diseases and can also be used to induce tolerance to at least one therapeutic composition, such as a therapeutic protein or transplanted tissue. 1. A method of tolerizing a subject to at least one therapeutic composition comprising a step in which said at least one therapeutic composition is coadministered to a subject with CD83, wherein said therapeutic composition is not a transplanted tissue. This application is a continuation of U.S. application Ser. No. 12/308,306, filed Dec. 11, 2008, a 371 of international PCT/US2007/018048, filed Aug. 16, 2007, which claims priority to U.S. Provisional Application No. 60/927,377, filed May 4, 2007 and U.S. Provisional Application No. 60/838,812, filed Aug. 18, 2006, the contents of both of which are specifically incorporated herein by reference.The present invention relates to improved methods of treating a subject so as to suppress or prevent undesired immune responses. The methods comprise the use of CD83 and tolerize a subject to a therapeutic composition. For example, the methods can be used to prevent rejection of transplanted tissue.The immune system of mammals is capable of mounting a protective response to a very large number of foreign antigens. Unfortunately, this very responsiveness can cause difficulties when it is directed to compounds that are intended for therapeutic use—including, for example, transplanted tissue, gene ...