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Transgene's Therapeutic Vaccine TG4010 Shows Promising Preliminary Phase IIb Data In Advanced Non-Small Cell Lung Cancer
Transgene
(Euronext Paris: FR0005175080) announces promising preliminary data from
the Phase IIb trial evaluating its therapeutic vaccine TG4010
(MVA-MUC1-IL2) as an adjunct to first line chemotherapy in patients with
advanced non-small cell lung cancer (NSCLC).
This on-going trial is a randomized, open label and controlled study
designed to assess the efficacy of TG4010 in combination with cisplatin and
gemcitabine compared to the chemotherapy regimen alone. The trial completed
the enrolment of 148 patients at the end of May 2007 and was conducted in
27 centres located in France, Poland, Germany, and Hungary. The patients
had NSCLC expressing MUC1, either stage IIIB with effusion or stage IV, and
had not received prior systemic treatment for their advanced disease. Half
of the patients received the combination regimen (TG 4010 vaccine plus
chemotherapy) and the other half of the patients received chemotherapy
alone.
The trial confirmed the favourable safety profile of TG4010 when
associated to chemotherapy: most adverse events observed so far were
considered related to chemotherapy as well as to the underlying disease.
Hematological toxicity was equivalent in both treatment groups. Most
frequent adverse events related to TG4010 were injection site reactions and
asthenia, which are classical vaccine associated reactions.
Based on the local evaluations performed at investigation centres,
results so far are showing a positive trend in favour of the combination of
TG4010 with the chemotherapy. These results nevertheless remain subject to
a centralised review process that is presently on-going.
"We report today encouraging trends on the preliminary results of our
Phase IIb trial with TG4010 in non-small cell lung cancer" said Philippe
Archinard, Chief Executive Officer of Transgene. "We expect to present data
during the second quarter of this year and final data by the fourth quarter
of 2008."
About TG4010 cancer vaccine
TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, a
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.
- TG4010 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 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
http://www.transgene.fr.
Cautionary note regarding forward-looking statements
This press release contains forward-looking statements referring to the
encouraging trends on preliminary results of one of Transgene's therapeutic
vaccine candidates. However, because these results are preliminary, are
based on local evaluations performed at the clinical trial centres and are
subject to an additional centralised review process by evaluation experts,
there can be no certainty that they will be confirmed. This additional
centralised review may lead to a different evaluation of the results,
positive or negative. 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 favourable
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.
http://www.transgene.fr
Transgene lui terapeutice Vaccin TG4010 Afiºeazã promitator fazei preliminare IIb datelor În avansatã Non-Small Cell Lung Cancer - Transgene's Therapeutic Vaccine TG4010 Shows Promising Preliminary Phase IIb Data In Advanced Non-Small Cell Lung Cancer - articole medicale engleza - startsanatate