A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical Trials

Takuma Matsuda, Hiroyo Karube, Atsushi Aruga

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
JournalTherapeutic Innovation and Regulatory Science
DOIs
Publication statusAccepted/In press - 2017 Jan 1

Fingerprint

Oncolytic Virotherapy
Clinical Trials
Safety
Viruses
Chills
United States Food and Drug Administration
Pharmaceutical Preparations
Nausea
Fatigue
Neoplasms
Fever
Therapeutics
Databases
Infection
Genes

Keywords

  • clinical trial
  • oncolytic virus therapy
  • regulatory science
  • risk assessment
  • safety

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

Cite this

A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical Trials. / Matsuda, Takuma; Karube, Hiroyo; Aruga, Atsushi.

In: Therapeutic Innovation and Regulatory Science, 01.01.2017.

Research output: Contribution to journalArticle

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