Oncolytic Viral Therapy Using Mutant Herpes Simplex Virus (HF10) for Cancer

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1. A pilot study using oncolytic herpes virus (HF 10) was initiated, preliminary to proceeding further research projects, in six patients with recurrent breast cancer. On the basis of the result from this pilot study, we have accumulated basic research data and clinical data for oncolytic virus therapy regarding safety and effectiveness.2. We have conducted a clinical trial for three patients with non-resectable pancreatic cancer under the approval of the Nagoya University School of Medicine. The intraoperative injection of HF10 into pancreatic tumor cell was performed with laparotomy. We assessed laboratory data of the trial, including white blood cell count, natural killer cells, IL12 and IFN. We observed no adverse effects in all patients, and kept monitoring their progress.3. We have launched new fundamental experiment regarding peritoneal injection of HF 10. We have accumulated basic date of survival rate and side effect using peritoneal disseminated cancer tumor mice model. We have also accumulated the data about host immune response against oncolytic virus. Anti virus antibody positive serum strongly inhibited virus activity.4. We studied about combination therapy of oncolytic virus (HF10) and chemotherapy drug in vitro and in vivo. Combination therapy of oncolytic virus and chemotherapy drug enhanced tumor-killing effect than single use.5. For the drug approval in future, we have completed a production process of GMP standard purified oncolytic virus (HF 10) in England.