Oncolytic Virus: Regulatory Aspects from Quality Control to Clinical Studies

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.