Supply of RetroNectin^® to UCLA for TCR-gene therapy clinical trials of advanced melanoma

Dec. 1, 2008 --- Takara Bio Inc. (President and CEO: Ikunoshin Kato, Ph.D.) has entered into a material transfer agreement with University of California at Los Angeles (UCLA) as of December 1st, 2008 to supply Takara Bio's RetroNectin^® for use in a Phase II clinical trial of advanced melanoma conducted by the group of Dr. Antoni Ribas. Twenty-two patients are expected to be enrolled in this trial.

In the UCLA clinical trial, peripheral blood mononuclear cells (PBMCs) collected from melanoma patients are retrovirally-transduced in vitro utilizing the RetroNectin^® method with a gene encoding T-cell receptor (TCR) which specifically recognizes tumor antigen MART-1 expressing on melanoma cells. The TCR-gene transduced PBMCs will be expanded in vitro and then infused back into the patients, so that the transduced PBMCs can specifically recognize and attack the tumor cells in the patients. Under the protocol, patients will also receive autologous dendritic cells (DC) processed ex vivo in addition to the TCR-gene transduced PBMCs, that are expected to enable enhancement of patients' immunity to attack the melanoma cells.

This is the 44th clinical trial in which the RetroNectin^® method has been used. Currently, ex vivo gene therapy is expanding throughout the world as an effective method for several incurable diseases. In this exciting environment, the RetroNectin^® method is being recognized as an essential and standard technology for ex vivo gene therapy.

[ 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.

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

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