RU2016150656A - Новые комбинации для антигенной терапии - Google Patents
Новые комбинации для антигенной терапии Download PDFInfo
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- RU2016150656A RU2016150656A RU2016150656A RU2016150656A RU2016150656A RU 2016150656 A RU2016150656 A RU 2016150656A RU 2016150656 A RU2016150656 A RU 2016150656A RU 2016150656 A RU2016150656 A RU 2016150656A RU 2016150656 A RU2016150656 A RU 2016150656A
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- autoantigen
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- 230000000890 antigenic effect Effects 0.000 title 1
- 238000002560 therapeutic procedure Methods 0.000 title 1
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Classifications
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Claims (22)
1. Способ профилактики и/или лечения аутоиммунного заболевания, включающий введение пациенту композиции, где указанная композиция содержит по меньшей мере один аутоантиген бета-клеток, путем внутрилимфатической инъекции или инъекции непосредственно в лимфатический узел.
2. Способ по п.1, где аутоантиген бета-клеток выбран из группы, состоящей из декарбоксилазы глутаминовой кислоты (GAD), антигена-2 инсулиномы, ZnT8, островково-специфического белка каталитической субъединицы глюкозо-6-фосфата (IGRP), хромогранина А, инсулина, В-цепи инсулина, препроинсулина или проинсулина.
3. Способ по п.1, где аутоантиген бета-клеток вводят в количестве 1-15 мкг, более предпочтительно, в диапазоне 2-10 мкг, и наиболее предпочтительно, в диапазоне 2-5 мкг на одну инъекцию и используемый аутоантиген.
4. Способ по пп.1, 2 или 3, включающий введение композиции, содержащей аутоантиген бета-клеток, по меньшей мере 2 раза, более предпочтительно, по меньшей мере 3 раза, и наиболее предпочтительно, по меньшей мере 4 раза, при этом каждое введение осуществляют по меньшей мере 14 дней друг от друга, более предпочтительно, по меньшей мере 30 дней друг от друга.
5. Способ по любому из пп. 1-4, дополнительно включающий введение пациенту ингибитора циклооксигеназы.
6. Способ по п.5, где ингибитор циклооксигеназы выбран из группы, состоящей из ибупрофена, дексибупрофена, напроксена, фенопрофена, кетопрофена, декскетопрофена, флурбипрофена, оксапрозина, локсопрофена, индометацина, толметина, сулиндака, этодолака, кеторолака, диклофенака, ацеклофенака, набуметона, ацетилсалициловой кислоты, дифлунизала (долобида), салициловой кислоты, салсалата (дисалцида), пироксикама, мелоксикама, теноксикама, дроксикама, лорноксикама, изоксикама, мефенамовой кислоты, меклофенамовой кислоты, флуфенамовой кислоты, толфенамовой кислоты, целекоксиба, рофекоксиба, вальдекоксиба, парекоксиба, лумиракоксиба, эторикоксиба и нимесулида.
7. Способ по любому из пп. 1-6, дополнительно включающий введение пациенту соединения CTLA4, такого как абатацепт.
8. Способ по любому из пп. 1-7, дополнительно включающий введение пациенту ингибитора TNF-альфа.
9. Способ по п.8, где ингибитор TNF-альфа выбран из группы, состоящей из адалимумаба, сертолизумаба, этанерцепта, голимумаба и инфликсимаба.
10. Способ по любому из пп. 1-9, дополнительно включающий введение пациенту витамина D, аналогов витамин D, ингибиторов тирозинкиназы, гамма-аминомасляной кислоты или аналога гамма-аминомасляной кислоты и/или воздействие на пациента УФB-излучения.
11. Способ по п.10, где введение витамина D и/или аналогов витамина D и/или воздействие УФB-излучения осуществляют в течение от 7 до 90 дней до введения пациенту композиции, содержащейпо меньшей мере один аутоантиген бета-клеток.
12. Способ по п.10 или 11, где способ включает введение витамина D и/или аналогов витамина D в количестве 7000-70000 международных единиц в неделю в течение 3-48 месяцев.
13. Способ по любому из пп. 11-12, включающий введение пациенту композиции по любому из пп. 51-58.
14. Способ по любому из пп. 1-13, где аутоиммунное заболевание представляет собой диабет 1 типа или аутоиммунный диабет.
15. Композиция, содержащая множество частиц, каждая из которых содержит иммобилизованные на поверхности по меньшей мере один первый и по меньшей мере один второй антиген, где первый антиген представляет собой аутоантиген бета-клеток, а второй антиген является либо толерогеном, либо аутоантигеном бета-клеток, при этом композиция дополнительно необязательно включает фармацевтически приемлемые адъюванты, эксципиенты, растворители и/или буферные агенты.
16. Композиция по п.15, где все аутоантигены бета-клеток выбраны из группы, состоящей из декарбоксилазы глутаминовой кислоты (GAD), антигена-2 инсулиномы, ZnT8, островково-специфического белка каталитической субъединицы глюкозо-6-фосфата (IGRP), хромогранина А, инсулина, В-цепи инсулина, препроинсулина или проинсулина.
17. Композиция по п.15 или 16, где по меньшей мере один аутоантиген бета-клеток представляет собой декарбоксилазу глутаминовой кислоты (GAD).
18. Композиция по любому из пп. 15-17, где по меньшей мере одним аутоантигеном бета-клеток является GAD-65.
19. Композиция по любому из пп. 15-18, где второй антиген представляет собой толероген.
20. Композиция по п.19, где толероген представляет собой нативный белок человека, такой как IL-10, сывороточный альбумин или гемоглобин человека, или гамма-аминомасляную кислоту.
21. Композиция по любому из пп. 15-20, где частица представляет собой частицу гидроксида алюминия (alum), липосому, наночастицу, частичку золота или биоразлагаемую частицу.
22. Композиция по любому из пп. 15-21, где каждая частица имеет иммобилизованные на поверхности 2, 3, 4, 5, 6, 7, 8, 9 или 10 различных антигенов, выбранных из группы, которая включает толерогены и аутоантигены бета-клеток.
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