Kusatsu/Shiga, Japan — May 29, 2017 — Takara Bio Inc. (Takara Bio), today announced that the first patient with melanoma has been enrolled into Oncolytic Virus HF10(TBI-1401) phase II clinical trial in Japan on May 26, 2017.
In this clinical study, HF10 is administered in combination with Ipilimumab in patients with unresectable or metastatic melanoma, and its efficacy and safety will be evaluated as well as immunological test. Also, the HF10 manufactured at Center for Gene and Cell, Takara Bio’s facility, is used in this study.
Takara Bio attempts to achieve the accelerated approval utilizing the conditional and term-limited approval system for regenerative medicine under “The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical devices”. Takara Bio aims to commercialize the HF10 cancer therapy in the fiscal year 2018 in Japan.
“Announcement on submission of the Clinical Trial Plan Notification for phase II clinical trial of Oncolytic virus HF10 in Japan” (Released on Jan 30)