Otsu/Shiga, Japan – October 31, 2012 – Takara Bio Inc. announced to expand Phase I clinical trial for HF10 anti-cancer therapy to start multiple dosing study. Takara Bio has been conducting a Phase I clinical trial of HF10 anti-cancer therapy in the U.S., and completed its single dosing study with 15 cases.
Intending to move the development program forward quickly, the protocol of the single dosing Phase I trial was amended to add a multiple dosing cohort, which had been planned to be conducted later. Following approval by the review committees of the clinical sites and the U.S Food and Drug Administration, Takara Bio started the multiple dosing study and the first patient was treated at Oregon Health and Science University on February 25, 2013.
In this study, the safety, tolerability and the efficacy of the multiple dose HF10 will be evaluated as well as the correlative immunological response in patients with refractory solid tumors and with cutaneous and/or superficial lesions.
Takara Bio continues trying to advance the clinical development of HF10, targeting its commercialization by March 2019.
[ About Takara Bio Inc. ]
Takara Bio Inc. is an innovative biotechnology company based in Shiga, Japan. As a world leader in biotechnology research and development, Takara Bio was the first company to market PCR technology in Japan and is also the developer of the RetroNectin® reagent, which is a world-standard in gene therapy protocols. In addition to providing research reagents and equipment to the life science research market, Takara Bio has active research and product development activities in the fields of gene and cell-based therapy, and agricultural biotechnology; and is committed preventing disease and improving the quality of life for all people through the use of biotechnology. Through strategic alliances with other industry leaders, the Company aims to extend its reach around the world. More information is available at http://www.takara-bio.com.