June 17, 2009 — Takara Bio Inc. (President & CEO: Koichi Nakao) entered into a material transfer agreement with Children’s Hospital Boston; Massachusetts in the U.S. as of June 15, 2009 to supply Takara Bio’s RetroNectin® for use in clinical trials on gene therapy of X-SCID, which is being conducted by the group of Dr. David Williams.


On this project, 5 institutes in the U.S.A., U.K. and France are to conduct clinical trials, and the company will provide the material to all of these institutes under the MTA. In total, twenty patients are expected to be enrolled in these trials.


X-SCID is a congenital combined immunodeficiency caused by mutations in gamma chain (γc), genes encoding common cytokine receptor, which was originally identified as a component of the high affinity interleukin-2 receptor (IL-2RG) playing a crucial role in proliferation and activation of immune cells in the body. It is said that its incidence is 1 out of approximately from 100,000 to 150,000. Death usually occurs in the first year of life from infections complications unless definitive treatment can be administered.


In this clinical trial, hematopoietic stem cells will be collected from patients and retrovirally transduced ex vivo with a gene encoding normal γc by utilizing the RetroNectin® method, and then infused back into the patients. The transduced stem cells differentiate into lymphocytes which regained the original function of γc in patients’ bodies, which is expected to result in reconstitution of the immune system in the these patients.


This is the 47th 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.