rpmjResearch'n Practical Medicine JournalResearch and Practical Medicine Journal2410-1893"QUASAR", LLC10.17709/2409-2231-2016-3-4-4rpmj-161Research ArticleОбзорыReviewГЕННО-ТЕРАПЕВТИЧЕСКИЕ ПРЕПАРАТЫ В ОНКОЛОГИИ: СОВРЕМЕННОЕ СОСТОЯНИЕOFFICIAL MEDICATIONS FOR ANTI-TUMOR GENE THERAPYhttps://orcid.org/0000-0002-3579-1733НемцоваЕ. Р.NemtsovaE. R.

Немцова Елена Романовна - доктор биологических наук, ведущий научный сотрудник отделения модификаторов  и протекторов противоопухолевой терапии.

125284 Москва, 2-й Боткинский пр., 3; E-mail: nemtz@yandex.ru

Elena R. Nemtsova – MD, leading researcher,  the department of the modifiers and protectors of anticancer therapy.

3, 2nd Botkinskiy proezd, Moscow, 125284, Russia; E-mail: nemtz@yandex.ru

nemtz@yandex.ruhttps://orcid.org/0000-0002-5009-1508БезбородоваО. А.BezborodovaO. A.

Безбородова Ольга Алексеевна - кандидат биологических наук, старший научный сотрудник отделения модификаторов и протекторов противоопухолевой терапии МНИОИ имени П. А. Герцена – филиал ФГБУ «НМИРЦ».

125284, Россия, Москва, 2-й Боткинский проезд, 3, E-mail: olgabezborodova@yandex.ru

Olga A. Bezborodova - PhD, senior researcher, the department of the modifiers and protectors of anticancer therapy.

3, 2nd Botkinskiy proezd, Moscow, 125284, Russia; E-mail: olgabezborodova@yandex.ru

olgabezborodova@yandex.ruhttps://orcid.org/0000-0002-9799-7622ЯкубовскаяР. И.YakubovskayaR. I.

Якубовская Раиса Ивановна - доктор биологических наук, профессор, заведующая отделением модификаторов и протекторов противоопухолевой терапии МНИОИ имени П. А. Герцена  – филиал ФГБУ «НМИРЦ».

125284, Россия, Москва, 2-й Боткинский проезд, 3, E-mail: raisayakub@yandex.ru

Raisa I. Yakubovskaya - MD, professor, head of the department of the modifiers and protectors of anticancer therapy.

3, 2nd Botkinskiy proezd, Moscow, 125284, Russia; E-mail: raisayakub@yandex.ru

raisayakub@yandex.ruhttps://orcid.org/0000-0001-8784-8415КапринА. Д.KaprinA. D.

Каприн Андрей Дмитриевич - академик  РАН, доктор медицинских наук, профессор, заведующий кафедрой урологии и оперативной нефрологии с курсом онкоурологии МИ РУДН, генеральный директор ФГБУ «НМИРЦ» Минздрава России.

125284, Россия, Москва, 2-й Боткинский проезд, 3

Andrey D. Kaprin – academician of RAS, PhD, MD, Prof.; Corr. member  of the Russian Academy of Education; Honored Physician of the Russian Federation; General Director of NMRRC, Head of Department of Urology with Course of Urological Oncology, Faculty for Postgraduate Training, PFU of Russia.

3, 2nd Botkinskiy proezd, Moscow, 125284, Russia

Московский научно-исследовательский онкологический институт имени П.А. Герцена, филиал Национального медицинского исследовательского радиологического центраРоссияP. Hertsen Moscow Oncology Research Institute, Branch of the National Medical Research Radiological CentreRussian Federation201609122016343343Copyright © Немцова Е.Р., Безбородова О.А., Якубовская Р.И., Каприн А.Д., 20162016Немцова Е.Р., Безбородова О.А., Якубовская Р.И., Каприн А.Д.Nemtsova E.R., Bezborodova O.A., Yakubovskaya R.I., Kaprin A.D.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpmj.ru/rpmj/article/view/161

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.

This is a review of modern literature data of official medications for anti-tumor gene therapy as well as of medications that finished clinical trials.

The article discusses the concept of gene therapy, the statistical analysis results of initiated clinical trials of gene products, the most actively developing directions of anticancer gene therapy, and the characteristics of anti-tumor gene medications.

Various delivery systems for gene material are being examined, including viruses that are defective in  replication (Gendicine™ and Advexin) and oncolytic (tumor specific conditionally replicating) viruses (Oncorine™, ONYX-015, Imlygic®).

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The authors declare that there are no conflicts of interest present.