2017

2017/01/30

Announcement on submission of the Clinical Trial Plan Notification for phase II clinical trial of Oncolytic virus HF10 in Japan

Kusatsu/Shiga, Japan — January 30, 2017 — Takara Bio Inc. (Takara Bio), today announced that the Clinical Trial Notification was submitted to PMDA (Pharmaceuticals and Medical Devices Agency; Japanese regulatory agency) to conduct phase II clinical trial of oncolytic virus HF10 (Development code: TBI-1401) in Japan.
 
The clinical trial will be conducted in patients with unresectable or metastatic melanoma to evaluate efficacy and safety with the intratumoral injections of HF10 in combination with intravenous ipilimumab. The HF10 manufactured at Center for Gene and Cell Therapy, Takara Bio’s facility, will be used in the clinical trial.
 
After the clearance, the protocol will be reviewed by each IRB (Institutional Review Board) and the study will be initiated.
 
Takara Bio is currently conducting Phase II clinical trial in the US and Phase I clinical trial in Japan. Based on the results which were obtained so far, the intratumoral injections of HF10 are safe and well-tolerated, and encouraging tumor response was demonstrated. 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.
 
【Overview of the Clinical Trial】

Study name Phase II Clinical Trial of combination with TBI-1401 (HF10) and ipilimumab in patients with unresectable or metastatic melanoma (stage IIIB, IIIC or IV)
Condition Patients with unresectable or metastatic melanoma
Main Endpoint Best overall response rate (BORR) based on irRC at Week 24
Estimated Enrollment 25
Duration April 2017 – June 2018
Site National Cancer Center Hospital, and others, total 12 sites

 

For more information:Corporate Communications, Takara Bio Inc. E-mail: bio-ir@takara-bio.co.jp

This article is translated from press release in Japanese for your convenience.

 
Forward-Looking Statements Statements in this news release, other than those based on historical fact, concerning the current plans, prospects, strategies and expectations of the Company and its Group represent forecasts of future results. While such statements are based on the conclusions of management according to information available at the time of writing, they reflect many assumptions and opinions derived from information that includes major risks and uncertainties. Actual results may vary significantly from these forecasts due to various factors. Factors that could influence actual results include, but are not limited to, economic conditions, especially trends in consumer spending, as well as exchange rate fluctuations, changes in laws and government systems, pressure from competitors’ prices and product strategies, decline in selling power of the Company’s existing and new products, disruptions to production, violations of our intellectual property rights, rapid advances in technology and unfavorable verdicts in major litigation.

return to top