溶瘤病毒药物非临床安全性评价的思考

doi:10.19803/j.1672-8629.2021.06.22

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 597-600.
DOI: 10.19803/j.1672-8629.2021.06.22

• 综述 • 上一篇

溶瘤病毒药物非临床安全性评价的思考

王欣, 苗玉发, 霍艳, 王三龙, 周晓冰^#, 耿兴超^*

中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京 100176

收稿日期:2021-02-18 出版日期:2021-06-15 发布日期:2021-07-02
通讯作者: ^*耿兴超,男,研究员,药物安全评价。E-mail：gengxch@nifdc.org.cn;^#为同共通信作者。
作者简介:王欣,女,硕士,副研究员,新药临床前安全性评价。
基金资助:
重大新药创制国家科技重大专项2018年度（2018ZX09201-017）

Pre-Clinical Evaluation of Oncolytic Virus Drugs

WANG Xin, MIAO Yufa, HUO Yan, WANG Sanlong, ZHOU Xiaobing^#, GENG Xingchao^*

National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs, Beijing 100176, China

Received:2021-02-18 Online:2021-06-15 Published:2021-07-02

摘要/Abstract

摘要： 溶瘤病毒药物（OVs）是一类新型的抗肿瘤生物药,是以结构改造型病毒为载体进行构建,选择性地感染肿瘤细胞并进行复制,溶解和破坏肿瘤组织,对正常组织不造成损伤。该类药物具有载体种类多样、携带外源基因片段广泛、抗肿瘤效果明显、临床可与多种药物联用的优点。溶瘤病毒药物同时属于基因治疗和生物技术药物范畴,对这类药物开展临床前安全性评价,既要遵从药物毒性研究的一般原则,还需要结合特点设计特殊的试验内容。研究内容主要包括一般毒性、安全药理、免疫毒性和免疫原性、生物分布、病毒脱落以及其他相关研究等。本研究详细介绍了各项研究内容及试验方法。

关键词: 溶瘤病毒, 基因治疗, 安全性评价, 毒理学, 生物分布, 病毒脱落

Abstract: Oncolytic viruses (OVs) are a new antitumor biological product. They are constructed based upon structurally modified viral vectors, infect tumor cells preferentially and reproduce themselves in tumors without damaging normal tissues. They enjoy some advantages in that they have diverse vectors, carry a wide range of foreign fragments, exert significant antitumor effects and can be combined with multiple drugs when used in clinic. Oncolytic virus drugs have the characteristics of both gene therapies and biotechnological drugs. During preclinical safety assessment, we should comply with the general principles of toxicological research of drugs and design special experiments in line with the properties of these drugs. The related research should focus on general toxicity, safety pharmacology, immunotoxicity and immunogenicity, biodistribution, shedding and other related studies. This article is intended to elaborate on the priorities of research and experimental methods concerning OVs.

Key words: oncolytic viruses, gene therapy, safety evaluation, toxicology, bio distribution, shedding

中图分类号:

R994.11

王欣, 苗玉发, 霍艳, 王三龙, 周晓冰, 耿兴超. 溶瘤病毒药物非临床安全性评价的思考[J]. 中国药物警戒, 2021, 18(6): 597-600.

WANG Xin, MIAO Yufa, HUO Yan, WANG Sanlong, ZHOU Xiaobing, GENG Xingchao. Pre-Clinical Evaluation of Oncolytic Virus Drugs[J]. Chinese Journal of Pharmacovigilance, 2021, 18(6): 597-600.

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溶瘤病毒药物非临床安全性评价的思考

Pre-Clinical Evaluation of Oncolytic Virus Drugs

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