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Transgene Extends Therapeutic Vaccine Candidate TG4040 Development Program Against Chronic Hepatitis C |
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02 Oct 2007 |
Treating Patients Who Have Relapsed After Standard Treatment
STRASBOURG, France | October 1, 2007 | Transgene S.A. (Eurolist Paris: FR0005175080) announces today that the first patients have been enrolled in a Phase I trial in Canada of its therapeutic vaccine candidate TG4040 (MVA-HCV). The trial is expected to treat approximately 24 patients that are chronically infected with the Hepatitis C Virus (HCV) and who have relapsed after standard treatment of Ribavirin and Pegylated-Interferon Alpha. The trial is sponsored by the University of Montreal and supported by the Canadian Network for Vaccines and Immunotherapies.
Patients will receive one subcutaneous injection of TG4040 per week over a 3-week period together with a boost injection at Month 6. Dosing will be escalated in several cohorts from 106 to 108 pfu per injection. The trial’s primary endpoint is safety whereas secondary endpoints are immune response to the vaccination and effect on viral load. Availability of safety data as well as preliminary viral and immunological data is planned by end of 2008.
Another Phase I study of TG4040 is currently being conducted in France on 15 HCV patients who have never received any other therapy for their condition. Preliminary results are expected at the end of 2007.
“We are very pleased to initiate this second Phase I trial of our therapeutic HCV vaccine”, said Philippe Archinard, Chief Executive Officer of Transgene. “Addressing a different patient population will provide us with additional and valuable data to assess the potential of our vaccine.”
About chronic hepatitis C:
Hepatitis C currently represents a major public health concern. The number of persons chronically infected with HCV in the world is estimated at 170 million to 200 million and hepatitis-C-related deaths at approximately 470 000 annually. Peak of incidence of HCV-related diseases is expected to occur in 2025-2030 in developed countries. HCV infection leads to liver diseases such as fibrosis, cirrhosis and liver carcinoma which are the prime reason for liver transplants. The current standard of care for patients infected with the HCV genotype 1 (a combination of Pegylated-Interferon Alpha and Ribavirin), effective in 50% of patients completing therapy, is lengthy and often poorly tolerated. In addition, a substantial number of patients never receive therapy. Therefore, there is a strong need for new alternative approaches, including combination therapies.
About TG4040:
Transgene’s TG4040 product candidate is based on the MVA virus carrying and expressing non-structural proteins (NS3, NS4 and NS5B) of the hepatitis C virus. The MVA vector is a highly attenuated strain of vaccinia virus that combines an extensive history of safety with the ability to stimulate a strong immune response to antigens.
About Transgene:
Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has one product which has completed Phase II trials (TG4001/R3484), two compounds in Phase II trials (TG4010 and TG1042) and one compound in Phase I studies (TG4040). Transgene has concluded a strategic partnership agreement with Roche for the development of its TG4001/R3484 therapeutic vaccine to treat HPV-mediated diseases. Transgene has bio-manufacturing capacities for viral-based vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at www.transgene.fr.
SOURCE: TRANSGENE
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