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Published on: April 15, 2016
A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical Trials
Takuma Matsuda1, Hiroyo Karube1, Atsushi Aruga1
1Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, Tokyo.
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.
Insights
Oncolytic virus therapy (OVT) shows a manageable safety profile in clinical trials, with most adverse events being infection-related symptoms. Further trials are encouraged to solidify OVT as a safe cancer treatment.
Area of Science:
- Oncology
- Virology
- Immunotherapy
Background:
- Oncolytic virus therapy (OVT) is an emerging cancer treatment modality.
- Genetically modified viruses are developed as oncolytic agents.
- The first OVT gained FDA approval in 2015, signaling growing clinical interest.
Purpose of the Study:
- To conduct a risk assessment of OVT based on existing clinical trial safety data.
- To evaluate the safety and toxicity profiles of OVTs.
- To encourage further clinical development of OVTs.
Main Methods:
- Systematic review of safety data from all available clinical trials of OVTs.
- Analysis of adverse events (AEs) reported in a publicly accessible database.
- Assessment of AE frequency, severity, and manageability.
Main Results:
- The most frequent AEs associated with OVT were infection-related symptoms like fatigue, chills, fever, and nausea.
- Few serious adverse events were observed across different viruses and gene modifications.
- Systemic OVT infusion led to a high incidence of AEs, but most were manageable with standard medications.
Conclusions:
- OVTs exhibit a generally favorable safety profile with manageable adverse events.
- Further clinical trials are necessary to address challenges and confirm the safety of OVTs for cancer treatment.
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