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溶瘤病毒:从质量控制到临床研究的监管方面。

Oncolytic Virus: Regulatory Aspects from Quality Control to Clinical Studies.

机构信息

Department of Pharmaceutical Sciences, Nihon Pharmaceutical University, Saitama, Japan.

Institute of Advance Medical and Engineering Technology for Aging, Kanazawa Institute of Technology, Ishikawa, Japan.

出版信息

Curr Cancer Drug Targets. 2018;18(2):202-208. doi: 10.2174/1568009617666170222142650.

DOI:10.2174/1568009617666170222142650
PMID:28228083
Abstract

Oncolytic viruses, which include both naturally occurring wild-type viruses/attenuated viruses and genetically modified viruses, have recently been developed for use in innovative cancer therapies. Genetically modified oncolytic viruses possess the unique ability to replicate conditionally as a unique gene therapy product. Since oncolytic viruses exhibit prolonged persistence in patients, viral shedding and transmission to third parties should be major concerns for clinical trials along with the clinical safety and efficacy. Accordingly, studies are now underway to establish the safety and efficacy of oncolytic viruses.

摘要

溶瘤病毒包括天然存在的野生型病毒/减毒病毒和基因修饰病毒,最近已被开发用于创新的癌症治疗方法。基因修饰的溶瘤病毒具有作为独特基因治疗产品条件性复制的独特能力。由于溶瘤病毒在患者体内持续存在时间较长,病毒脱落和传播给第三方应成为临床试验的主要关注点,同时还需要关注临床安全性和疗效。因此,目前正在进行研究以确定溶瘤病毒的安全性和疗效。

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