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Growth, Purification, and Titration of Oncolytic Herpes Simplex Virus
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Preclinical Safety Evaluation of Oncolytic Herpes Simplex Virus Type 2

Yang Wang1, Xiaobing Zhou2, Zhen Wu1

  • 11 National "111" Center for Cellular Regulation and Molecular Pharmaceutics, Key Laboratory of Fermentation Engineering (Ministry of Education), Hubei Provincial Cooperative Innovation Centre of Industrial Fermentation, Hubei Key Laboratory of Industrial Microbiology, Hubei University of Technology, Wuhan, P.R. China.

Human Gene Therapy
|December 1, 2018
PubMed

Insights

This study shows that the oncolytic herpes simplex virus type 2 (OH2) is safe for cancer treatment. Preclinical safety evaluations in mice and monkeys indicate OH2 is suitable for human clinical trials.

Area of Science:

  • Oncolytic virotherapy
  • Cancer therapeutics
  • Virology

Background:

  • Oncolytic virotherapy utilizes oncolytic viruses for selective tumor replication and cytotoxicity.
  • A novel oncolytic herpes simplex virus type 2 (oHSV-2), designated OH2, was previously engineered for human cancer treatment.
  • OH2 demonstrated genetic and biological stability, maintaining antitumor activity over multiple passages.

Purpose of the Study:

  • To conduct a systematic preclinical safety evaluation of OH2.
  • To assess the safety and suitability of OH2 for advancement into clinical trials.

Main Methods:

  • Acute toxicity testing in BALB/c mice.
  • Repeated dose toxicity studies in BALB/c mice and cynomolgus monkeys.
  • Biodistribution assays in various mouse models and cynomolgus monkeys.

Main Results:

  • OH2 exhibited no significant toxicity in acute and repeated dose studies.
  • Biodistribution studies confirmed the safety profile of OH2 in preclinical models.
  • The safety evaluation provides a strong basis for clinical trial initiation.

Conclusions:

  • The preclinical safety evaluation indicates that OH2 is safe and well-tolerated.
  • OH2 is suitable for further clinical investigation as a cancer therapeutic.
Keywords:
antitumor effectherpes simplex virus type 2safety evaluation

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