2017

2017/05/29

First patient enrolled into Oncolytic Virus HF10 phase II clinical trial in Japan

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.
 
(Reference)
“Announcement on submission of the Clinical Trial Plan Notification for phase II clinical trial of Oncolytic virus HF10 in Japan” (Released on Jan 30)

http://www.takara-bio.com/release/?p=611

 

For more information:PR・IR Department, Takara Bio Inc.
E-mail: bio-ir@takara-bio.co.jp

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

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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.

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