Transgene's Therapeutic Vaccine MVA-MUC1-IL2 at ASCO:
17 May 2005 - 3:01PM
PR Newswire (US)
Transgene's Therapeutic Vaccine MVA-MUC1-IL2 at ASCO: -
Confirmation of Phase II Positive Data In Non Small Cell Lung
Cancer STRASBOURG, France, May 17 /PRNewswire-FirstCall/ --
Transgene (Nasdaq: TRGNY; Eurolist Paris: FR0005175080) is pleased
to announce that Prof. Thierry Velu of the Erasme Hospital,
Brussels, Belgium, will present this morning the recently updated
results of a phase II clinical study with the therapeutic cancer
vaccine MVA-MUC1-IL2 in Non Small Cell Lung Cancer (NSCLC) at the
annual meeting of the American Society of Clinical Oncology (ASCO)
in Orlando, Florida. In this study, MVA-MUC1-IL2 was administered
simultaneously with cisplatin and vinorelbine in 44 stage IIIB/IV
patients with non-small-cell lung cancer. The chemo-immunotherapy
regimen achieved a tumor response rate of 37%: 13 partial responses
according to RECIST and validated by a central reading out of 35
patients evaluable for response. 71% of the patients showed disease
control (partial responses or stable disease for more than 12
weeks). At this time, the estimated, median time to progression
(TTP) and overall survival are 6.4 months and 13 months,
respectively. The proportion of patients alive one year after the
beginning of the treatment is 53%. All of these parameters compare
favourably to the results usually obtained with chemotherapy alone
in this population of patients. Additionally, these results are
particularly relevant regarding the profile of the study
population: the majority of the patients had stage IV disease and
all of them had MUC1 positive tumours, a tumour characteristic
associated with a poor prognosis. The overall survival of the
patients with a cellular immune response against MUC1 measured by
ELISPOT is significantly better (p=0.0035), suggesting that the
immunization against MUC1 contributes favourably to these results.
This study also strengthens the positive data obtained in the
prostate cancer Phase II trial conducted with MVA-MUC1-IL2, the
results of which were presented in the annual ASCO meeting on May
15, 2005. In addition, the vaccine is very well tolerated: local
site reactions, flu-like symptoms and fatigue are the most frequent
adverse events related to the product. No serious adverse event has
been related to MVA-MUC1-IL2 in clinical studies. "These
encouraging data and especially the long survival of the patients
presenting an immune response against MUC1 reinforce the concept of
using vaccine therapy to treat cancer and to extend remission",
declared Prof. Thierry Velu. "With the clinical and immunological
results obtained at this point, we met our objectives with our
MVA-MUC1-IL2 therapeutic cancer vaccine," said Philippe Archinard,
Chief Executive Officer of Transgene. "This provides a strong basis
supporting further development of the product. Our next step will
be a multicentric, randomized, controlled study evaluating the
impact of the vaccine in patients with the same profile who are
being treated with standard chemotherapy. The study is expected to
start by the end of 2005 and will enroll approximately 140 patients
in the European Union". About MVA-MUC1-IL2 cancer vaccine
Transgene's MVA-MUC1-IL2 uses the Modified Vaccinia Ankara virus
vector, a highly attenuated poxvirus that combines distinguishing
advantages for an optimized systemic vaccination. * MVA is a highly
attenuated strain which has been tested extensively in humans as a
smallpox vaccine and is known to strongly stimulate the immune
response to antigens. * MUC1 is a major tumor-associated antigen
that provides a viable target for vaccination. * MVA-MUC1-IL2
expresses the entire MUC1 gene sequence and has the potential to
generate an immune response to all antigenic epitopes of MUC1. *
The sequence coding for the cytokine Interleukin 2 (IL2) is
included to help stimulate specific T-cell response. About
Transgene Transgene, based in Strasbourg, France, is a
biopharmaceutical company dedicated to the discovery and
development of therapeutic vaccines and immunotherapy products for
the treatment of cancer and infectious diseases. Transgene has a
broad portfolio of products in clinical development. This press
release contains forward-looking statements referring to the
encouraging results of clinical testing of one of Transgene's
product candidates, and to the timing and nature of further
testing. However, as is the case with all biopharmaceutical
products under development, results from future studies with more
data may show less favorable outcomes, and there is no certainty
that they will ever demonstrate adequate therapeutic efficacy or
achieve regulatory approval or commercial use. Furthermore, product
testing and development depend on a variety of factors, including
the availability of adequate funding, the timing and success of
patient enrollment and the risk of unanticipated adverse patient
reactions. For a description of the risks facing the successful
development of Transgene's products, including uncertainty
regarding Transgene's ability to obtain financing for continued
operations, see Transgene's Annual Report on Form 20-F and its
other reports on file with the U.S. Securities and Exchange
Commission. DATASOURCE: Transgene CONTACT: Transgene, Patrick
Squiban, VP, Medical & Regulatory Affairs, +33-3-88-27-91-73;
Image 7, Tiphaine Hecketsweiler, +33-1-53-70-74-70 Web site:
http://www.transgene.fr/
Copyright