Takara Bio Inc, (Otsu, Japan) announced that its partner, MolMed S.p.A. (Milan, Italy) will present at the 47^th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, USA, on December 12, 2005, the results of a European PhaseI/II clinical trial of the HSV-TK gene therapy for hematological malignancies, confirming that the trial's primary endpoints, especially survival rates, were superior to conventional treatments. Following these data, MolMed plans to start in 2006 a Phase III randomised multicentric trial in Europe.
Takara Bio Inc. and MolMed S.p.A. have signed in 2003 an alliance agreement, under which Takara Bio Inc. acquires exclusive rights to commercialize the HSV-TK gene therapy in Asia, while MolMed S.p.A. acquires nonexclusive rights to perform Takara's RetroNectin technology in Europe and USA. Sharing clinical data as well as regulatory information obtained in each company's territory will allow a more rapid and effective development and commercialization of the HSV-TK gene therapy product.

Bone marrow transplantation (BMT) in combination with chemo- and/or radiotherapy is the most effective treatment for hematological malignancies such as leukemia, lymphoma and myeloma. However, the majority of patients can not benefit from BMT due to the lack of fully compatible donors. The HSV-TK gene therapy is an adjunctive therapy to BMT that allows patients lacking fully compatible donors to safely receive BMT from partially compatible (haplo-identical) family donors, such as their parents or children, since the therapy allows both a prompt reconstitution of the patient's immune system, and the control of the major complication of BMT, i.e. Graft versus Host Disease (GVHD), an immune attack of the donor's T cells against the patient's organs and tissues. If GVHD occurs, the patient receives a drug (ganciclovir) that leads to the selective elimination of the donor's T cells, thus abrogating GVHD while preserving the underlying bone marrow and native immune system unaffected.

MolMed's European trial TK007 is a Phase I/II multicentric study conducted in high risk acute leukemia patients and treated with haplo-identical Hematopoietic Stem Cell Transplantation (Haplo-HSCT) followed by infusion of HSV-TK suicide gene-engineered donor T-lymphocytes (TK-DLI). The results confirm that the adjunctive treatment with TK-DLI proved to be an effective tool for promoting immune reconstitution and improves safety and efficacy of Haplo-HSCT, thus increasing feasibility of transplantation from partially incompatible family donors.

Following these promising results, MolMed S.p.A. will move forward to a Phase III randomized multicentric study in Europe. Takara Bio Inc. is currently in the regulatory process to start a Phase I/II clinical trial of HSV-TK in patients affected by leukemia in Japan within 2006.

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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