PMID- 29714547
OWN - NLM
STAT- MEDLINE
DCOM- 20190219
LR  - 20220331
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 52
IP  - 4
DP  - 2018 Jul
TI  - A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on 
      Clinical Trials.
PG  - 430-437
LID - 10.1177/2168479017738979 [doi]
AB  - Oncolytic virus therapy (OVT) represents a new class of therapeutic agents in 
      cancer treatment. The molecular and cellular mechanisms of action of OVTs have 
      been evaluated in nonclinical/clinical phase trials. Various genetically modified 
      viruses have been developed as oncolytic agents, and the first approval of an OVT 
      for clinical use was issued by the US Food and Drug Administration in 2015. In 
      this context, more and more clinical development of OVTs is anticipated in the 
      future. This article provides a risk assessment of OVT based on the safety data 
      obtained from all clinical trials to date using a publicly available database. 
      The most common adverse events (AEs) observed in clinical trials have been 
      infection-related symptoms such as fatigue, chills, fever, and nausea; few 
      serious AEs have been observed, regardless of the kind of virus or transfected 
      genes. In vivo systemic infusion of OVTs demonstrated a high percentage of AEs, 
      but most AEs were manageable using common drugs. This paper describes OVTs' 
      specific safety/toxicity profiles and encourages the performance of further 
      clinical trials of OVTs to address the most serious challenges anticipated in the 
      development of OVTs as a new class of drugs for the treatment of cancer.
FAU - Matsuda, Takuma
AU  - Matsuda T
AUID- ORCID: 0000-0001-8642-2690
AD  - Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo 
      Women's Medical University and Waseda University, Tokyo.
FAU - Karube, Hiroyo
AU  - Karube H
AD  - Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo 
      Women's Medical University and Waseda University, Tokyo.
FAU - Aruga, Atsushi
AU  - Aruga A
AD  - Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo 
      Women's Medical University and Waseda University, Tokyo.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20171121
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
SB  - IM
MH  - Clinical Trials as Topic
MH  - Drug Approval
MH  - Humans
MH  - Neoplasms/*therapy
MH  - Oncolytic Virotherapy/*adverse effects
MH  - Oncolytic Viruses/classification
MH  - Risk Assessment
MH  - United States
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - clinical trial
OT  - oncolytic virus therapy
OT  - regulatory science
OT  - risk assessment
OT  - safety
EDAT- 2017/01/01 00:00
MHDA- 2019/03/21 06:00
CRDT- 2018/05/02 06:00
PHST- 2017/01/01 00:00 [pubmed]
PHST- 2019/03/21 06:00 [medline]
PHST- 2018/05/02 06:00 [entrez]
AID - 10.1177/2168479017738979 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2018 Jul;52(4):430-437. doi: 10.1177/2168479017738979. Epub 
      2017 Nov 21.