RU2007135185A - Продление времени до прогрессирования заболевания или продолжительности жизни у онкологических больных с применением ингибиторов димеризации her - Google Patents
Продление времени до прогрессирования заболевания или продолжительности жизни у онкологических больных с применением ингибиторов димеризации her Download PDFInfo
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Claims (37)
1. Способ продления времени до прогрессирования заболевания (TTP) или продолжительности жизни онкологического пациента, включающий введение пациенту ингибитора димеризации HER в количестве, которое способно продлить TTP или продолжительности жизни пациента, где при онкологическом заболевании пациента проявляется активация HER.
2. Способ по п.1, в котором ингибитор димеризации HER представляет собой ингибитор димеризации HER2.
3. Способ по п.2, в котором ингибитор димеризации HER ингибирует гетеродимеризацию HER.
4. Способ по п.1, где при онкологическом заболевании пациента проявляется активация HER2.
5. Способ по п.1, где при онкологическом заболевании пациента проявляется фосфорилирование HER2.
6. Способ по п.5, где при онкологическом заболевании пациента проявляется фосфорилирование HER2, которое оценивают в анализе фосфо-ELISA.
7. Способ по п.4, где при онкологическом заболевании пациента проявляется активация HER2, которую оценивают определением профиля экспрессии генов.
8. Способ по п.1, в котором ингибитор димеризации HER представляет собой антитело.
9. Способ по п.8, в котором антитело связывается с рецептором HER, выбранным из группы, состоящей из EGFR, HER2 и HER3.
10. Способ по п.9, в котором антитело связывается с HER2.
11. Способ по п.10, в котором антитело против HER2 связывается с доменом II внеклеточного домена HER2.
12. Способ по п.11, в котором антитело связывается с областью соединения между доменами I, II и III внеклеточного домена HER2.
13. Способ по п.12, в котором антитело против HER включает аминокислотные последовательности вариабельного домена легкой цепи и вариабельного домена тяжелой цепи SEQ ID №№3 и 4 соответственно.
14. Способ по п.13, в котором ингибитор димеризации HER представляет собой пертузумаб.
15. Способ по любому из пп.8-14, в котором антитело против HER представляет собой «голое» антитело.
16. Способ по любому из пп.8-14, в котором антитело против HER представляет собой интактное антитело.
17. Способ по любому из пп.8-14, в котором антитело против HER представляет собой фрагмент антитела, включающий антигенсвязывающую область.
18. Способ по пп.1-14, где онкологическое заболевание выбрано из группы, состоящей из рака яичников, рака брюшной полости, рака фаллопиевых труб, метастатического рака груди (MBC), немелкоклеточного рака легких (NSCLC), рака простаты и колоректального рака.
19. Способ по п.18, где онкологическое заболевание представляет собой рак яичников, брюшной полости или фаллопиевых труб.
20. Способ по п.18, где онкологическое заболевание является запущенным, рефрактерным или рецидивным раком яичников.
21. Способ по пп.1-14, в котором ингибитор димеризации HER вводят в качестве единственного противоопухолевого средства.
22. Способ по любому из пп.1-14, включающий введение пациенту второго терапевтического средства.
23. Способ по п.22, в котором второе терапевтическое средство выбрано из группы, состоящей из химиотерапевтического средства, антитела против HER, антитела, направленного против антигена, связанного с опухолью, антигормонального соединения, кардиопротектора, цитокина, лекарственного средства, нацеленного на EGFR, антиангиогенного средства, ингибитора тирозинкиназы, ингибитора COX, нестероидного противовоспалительного средства, ингибитора фарнезилтрансферазы, антитела, которое связывает онкофетальный белок CA 125, вакцины против HER2, терапии, нацеленной на HER, ингибиторов raf или ras, липосомального доксорубицина, топотекана, таксана, двойного ингибитора тирозинкиназы, TLK286, EMD-7200, лекарственного средства, лечащего тошноту, лекарственного средства, которое предотвращает или лечит сыпь на коже, или стандартной терапии против угрей, лекарственного средства, которое лечит или предотвращает диарею, лекарственного средства для понижения температуры тела, а также гематопоэтического фактора роста.
24. Способ по п.23, в котором второе лечебное средство представляет собой химиотерапевтическое средство.
25. Способ по п.24, в котором химиотерапевтическое средство представляет собой антиметаболическое химиотерапевтическое средство.
26. Способ по п.25, в котором антиметаболическое химиотерапевтическое средство является гемцитабином.
27. Способ по п.22, в котором второе терапевтическое средство представляет собой трастузумаб, эрлотиниб или бевацизумаб.
28. Способ по любому из пп.1-14, 19, 20, 23-27, в котором продлевается TTP.
29. Способ по любому из пп.1-14, 19, 20, 23-27, в котором продлевается продолжительность жизни.
30. Способ по любому из пп.1-14, 19, 20, 23-27, где введение ингибитора димеризации HER продлевает TTP или продолжительность жизни, как минимум, примерно на 20% больше, по сравнению с продлением TTP или продолжительности жизни, которые достигаются при введении онкологическому больному утвержденных противоопухолевых средств.
31. Способ продления времени до прогрессирования заболевания (TTP) или продолжительности жизни пациента, имеющего рак яичников, брюшной полости или фаллопиевых труб, включающий введение пациенту пертузумаба в количестве, которое продлевает TTP или продолжительность жизни пациента, где при онкологическом заболевании пациента проявляется активация HER2.
32. Способ по п.31, где у пациента имеется рак яичников.
33. Способ по п.31 или 32, где у пациента имеется запущенный, рефрактерный или рецидивный рак.
34. Способ по п.31 или 32, где введение пертузумаба пациенту продлевает TTP или продолжительность жизни пациента, как минимум, примерно на 20% больше, по сравнению с продлением TTP и продолжительности жизни, которые достигаются при введении пациенту топотекана или липосомального доксорубицина.
35. Способ по п.31 или 32, дополнительно включающий введение пациенту химиотерапевтического средства.
36. Способ по п.35, в котором химиотерапевтическое средство представляет собой антиметаболическое химиотерапевтическое средство.
37. Способ по п.36, в котором антиметаболическое химиотерапевтическое средство представляет собой гемцитабин.
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