Title:Oncolytic Virus: Regulatory Aspects from Quality Control to Clinical Studies
Volume: 18
Issue: 2
Author(s): Teruhide Yamaguchi*Eriko Uchida
Affiliation:
- Department of Pharmaceutical Sciences, Nihon Pharmaceutical University, Saitama,Japan
Keywords:
Oncolytic virus, gene therapy, cancer therapy, replicating virus, genetically modified viruses, clinical safety and
efficacy.
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.
