National Cancer Center in Japan gains a regulatory approval of the clinical research for HSV-TK "haplo add-back" gene therapy in treatment of leukemia

April 22, 2009 --- Takara Bio Inc. (President & CEO: Ikunoshin Kato, Ph.D.) announces that the gene therapy clinical research protocol for treatment of leukemia, which had been submitted by National Cancer Center (NCC) in Japan, was approved by Committee on Scientific Technology of Health Sciences Council, Ministry of Health, Labor, and Welfare held on April 15, 2009. The title of the approved protocol is "'Add-back' therapy with HSV-TK transduced donor lymphocytes after transplantation of T-cell-depleted hematopoietic stem cells from a haploidentical donor". The clinical research is going to be conducted at NCC in collaboration with Takara Bio, and is expected to be started after receiving an official notice from Japanese Health Minister and going through some internal procedures.

In this gene therapy, patients with high-risk hematopoietic malignancies receive hematopoietic stem cell transplantation from haploidentical donors (haplo-HSCT), which is followed by infusion ("add-back") of donor lymphocytes transduced with HSV-TK gene. Add-back of the HSV-TK transduced donor lymphocytes enables to reduce the risk of complications such as infections associated with haplo-HSCT, while severe Graft versus Host Disease (GVHD) can be controlled by the action of HSV-TK. This add-back therapy allows patients with lacking fully compatible donors to safely receive haplo-HSCT.

Under the mutual license agreements between the parties, Takara Bio acquired an exclusive right from an Italian biotech company, MolMed S.p.A., to commercialize HSV-TK gene therapy for hematological malignancies in Asian countries, while MolMed is granted a right to use Takara Bio's proprietary RetroNectin^® technology non-exclusively in the United States and Europe. MolMed is now conducting a Phase III randomized-controlled trial in Italy of the TK therapy in high risk acute leukaemia, and it plans to expand the clinical trial to other European countries in 2009, and to the United States after 2009.

Takara Bio has been developing HSV-TK gene therapy for hematopoietic malignancies in collaboration with NCC. In October 2008, Takara Bio started its Phase I clinical trial at the NCC Hospital of donor lymphocyte infusion (DLI) therapy using HSV-TK transduced lymphocytes for relapsed leukemia, which differs from the haplo add-back therapy in target patients and clinical protocols.

[ 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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