Takara Bio Inc. (President and CEO: Ikunoshin Kato, Ph.D.) has entered into a license and material transfer agreement with the Peter MacCallum Cancer Centre in Melbourne, Australia to supply Takara Bio's RetroNectin¨ for use in a phase I clinical trial of multiple myeloma (MM), which is being conducted by the group of principal investigator Professor Miles Prince. Six patients are expected to be enrolled in this phase I trial.

MM is a malignant hematological disease of the body's antibody producing cells, which causes them to grow out of control in the bone marrow, resulting in severe symptoms such as dissolution of the surrounding bone, aberration of the immune system, and renal damage. The yearly incidence of MM is approximately 2-3 per 100,000, with an increasing incidence in the elderly. The median survival of MM patients treated with standard dose chemotherapy is only about three years. Thus, there is a need for alternative treatments with improved efficacy.

In the Peter MacCallum Cancer Centre protocol, T cells collected from MM patients are retrovirally transduced in vitro utilizing the RetroNectin method with a gene encoding a chimeric receptor that specifically recognizes the oligosaccharide antigen, Lewis-Y, expressed on malignant MM cells. Following expansion of transduced T cells in the laboratory; MM patients will be infused with these modified T cells. The gene-transduced T cells express the Lewis-Y-specific chimeric receptor, which recognizes the Lewis-Y antigen on malignant MM cells, inducing the T cells to specifically attack the malignant cells. Based on this concept, Professor Prince's group has shown that the growth in mice of human ovarian tumor cells expressing Lewis-Y antigen, is significantly inhibited in 89% of mice treated with genetically-modified anti-Lewis-Y-specific T cells (P.N.A.S., vol. 102, 19051-19056, 2005).

This is the 41st clinical trial in which the RetroNectin method has been used, and is the first time the RetroNectin method has been used a clinical trial conducted outside Japan, Europe or the United States. Currently, ex vivo gene therapy is expanding throughout the world as an effective treatment 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.

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.

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