Pre-Clinical Evaluation of Oncolytic Virus Drugs

doi:10.19803/j.1672-8629.2021.06.22

Abstract

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

CLC Number:

R994.11

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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