STRASBOURG, France, February 13 /PRNewswire-FirstCall/ -- Transgene S.A. announces today 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 is part of a development programme supported by Lyonbiopole, one of France’s six world-class competitiveness clusters.
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 3-week period. Dosing will be escalated from 106 pfu (3 patients), 107 pfu (3 patients), to 108 pfu (9 patients). The patients treated with the highest dose will receive a boost injection of TG4040 at Month 6. The trial’s primary endpoint is safety and secondary endpoints are immunological response to the vaccination and effect on viral load.
Availability of safety data is planned by year end 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 (CIN2/3) caused by Human Papilloma Virus infection.
“We are very pleased to have our new vaccine candidate TG4040 entering clinical development”, said Philippe Archinard, Chief Executive Officer of Transgene. “We believe that TG4040 is a promising candidate to address the largely unmet medical need of treating chronic hepatitis C infection. This trial initiation shows our further commitment to apply therapeutic vaccination in the field of infectious diseases following our recent positive results with TG4001 in cervical precancerous lesions caused by Human Papilloma Virus.”
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 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.
In January 2006, Transgene was awarded a EUR1.3 million grant by the Lyonbiopole Competitiveness Cluster for the development of its therapeutic vaccine TG4040 against hepatitis C chronic infection. The funding, which originates from the French Ministry of Industry, is expected to cover approximately 30% of the research and development costs for this programme.
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 three compounds in Phase II trials and one compound in Phase I studies. Transgene has bio-manufacturing production capacities for viral-based vectors and technologies available for out-licensing. For further information about Transgene, please visit www.transgene.fr.
Cautionary note regarding forward-looking statements
This press release contains forward-looking statements referring to the planned clinical testing and development of one of Transgene’s therapeutic vaccine candidates. However, clinical testing and successful product development depend on a variety of factors, including the timing and success of future patient enrolment and the risk of unanticipated adverse patient reactions. Results from future studies with more data may show less favorable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval or commercial use. For further information on the risks and uncertainties involved in the testing and development of Transgene’s product candidates, see Trangene’s Document de reference on file with the French Autorite des marches financiers on its website at http://www.amf-france.org and Transgene’s website at http://www.transgene.fr .
Transgene S.A.
CONTACT: Press Contacts: Transgene, Philippe Poncet, +33-3-88-27-91-21.Capital MS&L, Mary Clark, Halina Kukula, +44-(0)20-7307-5330. Image 7,Estelle Guillot-Tantay, Tiphaine Hecketsweiler, +33-1-53-70-74-93
