TRANSGENE INITIATES STUDY OF HCV THERAPEUTIC VACCINE

Transgene announced that the first patients have been enrolled in a Phase I trial of its therapeutic vaccine candidate TG4040 (MVA-HCV) for patients chronically infected with the hepatitis C virus (HCV).

The trial, conducted in France, will enroll 15 chronically infected patients who have never received any therapy for their condition. The patients will receive one subcutaneous injection of TG4040 per week over a three-week period. The patients treated with the highest dose will receive a boost injection of TG4040 at month six. The trial's primary endpoint is safety, and secondary endpoints are immunological response to the vaccination and effect on viral load.

The company plans to announce safety data by the end of 2007 and virological and immunological response parameters by the third quarter of 2008.

TG4040, which expresses non-structural proteins of the hepatitis C virus, aims at inducing a strong and broad immune response against the infected cells. TG4040 shares the same MVA-vector technology as Transgene's other infectious-disease therapeutic vaccine TG4001, which has been shown to be effective in a Phase II trial for the treatment of patients with high-grade cervical intraepithelial neoplasia caused by human papillomavirus infection.

Last year Transgene was awarded a 1.3 million euro grant by the Lyonbiopole Competitiveness Cluster for the development of its therapeutic vaccine TG4040 against hepatitis C chronic infection.