ГЕННО-ТЕРАПЕВТИЧЕСКИЕ ПРЕПАРАТЫ В ОНКОЛОГИИ: СОВРЕМЕННОЕ СОСТОЯНИЕ

В обзорной статье рассмотрены современные данные мировой литературы об официальных лекарственных препаратах для генной терапии больных со злокачественными опухолями, а также данные о препаратах, завершивших все фазы клинических испытаний.

Освещена концепция генной терапии, приведены результаты статистического анализа инициированных клинических испытаний генных препаратов, указаны наиболее активно развивающиеся направления противоопухолевой генной терапии, подробно охарактеризованы препараты для онкологии.

Рассмотрены различные векторные системы доставки генетического материала – дефектные по репликации вирусы (препараты Gendicine™ и Advexin) и онколитические (опухолеспецифические условно размножающиеся) вирусы (препараты Oncorine™, ONYX-015, Imlygic®).

К настоящему времени в онкологическую клиническую практику введены 3 препарата для внутриопухолевого введения: 2 препарата зарегистрированы в Китае – Gendicine™ и Oncorine™ на основе дефектного по репликации и реплицирующегося аденовируса с эффекторным геном р53 дикого типа для лечения больных с опухолями головы-шеи, и 1 препарат зарегистрирован в США – Imlygic® на основе биоинженерного реплицирующегося штамма HSV1 с эффекторным геном GM–CSFдля лечения больных с меланомой. Препараты хорошо переносятся больными, не вызывают серьезных нежелательных явлений. Препараты Gendicine™ и Oncorine™ в монотерапии слабоэффективны, но проявляют выраженный синергизм действия с химиои лучевой терапией. Imlygic® – на начальной стадии изучения.

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