Takara Bio Inc. to supply RetroNectin^® to University of Washington School of Medicine for gene therapy targeting glioblastoma, a type of malignant brain tumors

Sep 29, 2008 --- Takara Bio Inc. (President and CEO: Ikunoshin Kato, Ph.D.) entered into a material transfer agreement with University of Washington School of Medicine (UWSM) in the U.S. to supply Takara Bio's RetroNectin^® for use in UWSM's phase I clinical trial of glioblastoma, which is being conducted by Prof. Hans-Peter Kiem and his research team.

Glioblastoma is classified as the most severe type among malignant brain tumors. Median survival after diagnosis is approximately 12 months, which demonstrates its intractability. In general, glioblastoma is very difficult to remove completely, so chemotherapy or radiation therapy is usually conducted after the operation. However, a significant obstacle to the treatment has been the hematopoietic toxicity of chemotherapeutic agents, which results in its dosage limitation.

To overcome this limiting factor, Prof. Kiem's group conducts the following therapy. The hematopoietic stem cells (CD34+cells) collected from patients are retrovirally transduced ex vivo by utilizing the RetroNectin^® method with a chemo-resistance gene, mutant MGMT, called MGMT-P140K. Subsequently, the patients' genetically-modified cells will be reinfused. As a result, it is expected that the genetic modification will render the peripheral blood stem cells (PBSCs) resistant to the chemotherapy; hence it will allow the administration of higher doses of anti-tumor drugs without accompanying myelosuppression, which potentially can improve the efficacy of treatment. This phase I trial will enroll approximately 15 to 30 patients.

This is the 43^rd clinical trial in which the RetroNectin^® method has been used. Ex vivo therapy is expanding throughout the world as an effective treatment method for several incurable diseases. In this dynamic 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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