title: Oncolytic Virus: Regulatory Aspects from Quality Control to Clinical Studies.
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.
authors.affiliation: Department of Pharmaceutical Sciences, Nihon Pharmaceutical University, Saitama, Japan.
authors.forename: Teruhide
authors.initials: T
authors.lastname: Yamaguchi
authors.affiliation: Department of Pharmaceutical Sciences, Nihon Pharmaceutical University, Saitama, Japan.|Institute of Advance Medical and Engineering Technology for Aging, Kanazawa Institute of Technology, Ishikawa, Japan.
authors.forename: Eriko
authors.initials: E
authors.lastname: Uchida
mesh_terms: D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D003257:Consumer Product Safety; D006801:Humans; D009369:Neoplasms / Q000235:genetics / Q000628:therapy*; D050130:Oncolytic Virotherapy; D050504:Oncolytic Viruses / Q000235:genetics*; D011786:Quality Control
keywords: Oncolytic virus; cancer therapy; clinical safety and
  efficacy; gene therapy; genetically modified viruses; replicating virus