Otsu/Shiga, Japan – May 1, 2014 – Takara Bio Inc. announced today that it has submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) dated April 30, 2014 in order to conduct a phase II clinical trial in the United States of the oncolytic virus HF10 in patients with unresected or metastatic malignant melanoma.
In this trial, the efficacy, safety and tolerability of HF10 treatment in combination with Ipilimumab (YERVOY®), anti-CTLA-4 monoclonal antibody, will be evaluated in patients with Stage IIIB, IIIC or IV unresected or metastatic malignant melanoma. The principal investigator of the study will be Dr.Robert Andtbacka, an associate professor of surgical oncology in the Department of Surgery, University of Utah Huntsman Cancer Institute. Approximately nine clinical sites in the USA will participate in the study. It is planned that at least 43 patients will be enrolled during the 2 year study period. The enrollment will start following FDA review and the approval from the review committees of the clinical sites.
As of April 4, Takara Bio had completed enrollment of a Phase I clinical trial of HF10 in patients with solid tumors in the US. This trial was conducted to evaluate single and repeated intratumoral injections of the oncolytic virus, HF10. Based on the results of the Phase I, treatment with intratumorally-injected HF10 was found to be well tolerated in multiple types of solid tumor malignancies.
Takara Bio aims to commercialize the HF10 anti-cancer therapy by the fiscal year ending in 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 including functional food and mushroom production businesses; 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.