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TRANSGENE ANNOUNCES PROMISING PHASE I PRELIMINARY RESULTS OF ITS HCV THERAPEUTIC VACCINE
Preliminary
analysis demonstrates a favourable safety profile and shows anti-viral
activity of TG4040 on chronically infected treatment-naïve patients
Strasbourg,
France, May 19th, 2008 - Transgene S.A. (Euronext Paris: FR0005175080)
announces today the preliminary results of the ongoing Phase I trial
for its therapeutic vaccine TG4040 (MVA-HCV) conducted in patients
chronically infected with the Hepatitis C Virus (HCV).
The
trial, conducted in three sites in France, enrolled 15 treatment-naive
patients chronically infected with the genotype 1 HCV. The patients
received three weekly subcutaneous injections of TG4040. Dosing was
escalated from 106 pfu (three patients), to 107 pfu (three patients),
and to 108 pfu (nine patients). Patients treated with the highest dose
will also receive a boost injection of TG4040 at month 6.
Preliminary
analysis performed on the 15 patients after the three weekly
injections, but prior to receiving the boost injection, shows that
TG4040 has a favourable safety profile across all doses. The most
common side effects are mild to moderate injection site reactions. On
April 30th, 2008 the Independent Safety Committee stated that it had no
safety concerns and indicated that it is appropriate to continue the
study.
Furthermore, six out of the 15 patients experienced a
viral load reduction ranging from 0.5 to 1.4 log10, clearly indicating
an effect of the vaccine on viral replication.
"These results,
despite their preliminary and partial nature, are very encouraging and
indicate that TG4040 is active against hepatitis C", said Philippe
Archinard, Chief Executive Officer of Transgene. "These initial Phase I
results clearly support pursuing and intensifying the clinical
development of this novel therapeutic approach. We expect to present
more detailed data, including boost vaccination results, by the fourth
quarter of 2008."
About TG4040 clinical development programme:
Since 2007, Transgene has initiated a significant exploratory Phase I programme with its TG4040 therapeutic vaccine:
- A Phase I trial was initiated in France in February 2007 enrolling 15 treatment-naïve patients;
-
This French trial was extended to include patients with more advanced
stages of liver disease, in order to potentially enlarge the target
patient population, and also to assess shortened booster vaccination
schedules. The enrolment of up to 27 patients started in March 2008;
-
A Phase I study in Canada was initiated in October 2007 enrolling 24
patients who have relapsed after standard treatment. The trial is
sponsored by the University of Montréal and is supported by the
Canadian Network for Vaccines and Immunotherapies.
About TG4040:
Transgene's
TG4040 product 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 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 reasons for liver transplants. The current standard of
care for patients infected with the HCV genotype 1 (a combination of
pegylated interferon alpha and ribavirin) is lengthy, often poorly
tolerated and at most effective in 50% of patients completing therapy.
In addition, a substantial number of patients never receive therapy.
Therefore, there is a strong medical need for new alternative
approaches, including combination therapies.
About Transgene:
Transgene,
based in Strasbourg, is a 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 référence on file with
the French Autorité des marchés financiers on its website at
http://www.amf-france.org and Transgene's website at www.transgene.fr .
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