HSV-TK gene therapy drug for leukemia was confirmed by MHLW the conformity to the guideline on gene therapy drugs

Sep 6, 2007 --- Takara Bio's Application for the confirmation of conformity to the guideline on gene therapy drugs, which is indispensable to start a clinical trial of gene therapy for Leukemia using HSV-TK suicide gene in Japan, was passed by the review of Committee of Handling Regulations for Biological Products, Pharmaceutical Affairs and Food Sanitation Council (PAFSC) on September 5^th, 2007.

After PAFSC submitting a report to Pharmaceutical Affairs Department, we are supposed to receive a review result from MHLW (Ministry of Health, Labour and Welfare). It is the first time that gene therapy product for ex vivo gene therapy was confirmed the conformity to the guideline.

This HSV-TK gene therapy is to be applied for donor lymphocyte Infusion (DLI) to treat recurrent leukemia after allogenic hematopoietic stem cell transplantation.

Although DLI therapy is highly effective against a variety of leukemia, graft versus host disease (GVHD) is known to be a critical side effect. It is expected that this HSV-TK gene therapy is effective against GVHD.

The HSV-TK gene is transduced into lymphocytes, which are derived from the donor of allogenic hematopoietic stem cell transplantation, in the ex vivo setting with retrovirus vector and administrated into a patient.

On the occurrence of GVHD, administrating ganciclovir to the patient leads to the suicide mechanism of HSV-TK and resolves GVHD by killing donor lymphocytes.

We aim at initiating a clinical trial of HSV-TK gene therapy for recurrent leukemia in Japan by the fiscal year of 2008.

[ 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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