- Treating Patients who Have Relapsed After Standard Treatment
STRASBOURG, France, Oct. 1 /CNW/ - 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.
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.
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.
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.
For further information:
For further information: Investor contacts: Transgene, Philippe Poncet,
Chief Financial Officer, Phone: + 33-3-88-27-91-21; Press contacts: Capital
MS&L, Mary Clark, Halina Kukula, Phone: +44-20-7307-5330