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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/