STRASBOURG, France, January 10 /PRNewswire-FirstCall/ -- Transgene 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 previous TG4010 clinical data
Non-controlled Phase II data are available at: http://www.transgene.fr/us/pdf/communique_presse/communiques_divers_2005/PR-U S_17-05-2005_ASCO_POUMON.pdf (Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser’s URL address field. Remove the space if one exists.)
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.
CONTACT: Investor contacts: Press contacts: Transgene: Philippe Poncet,
Chief Financial Officer, Phone: +33-3-88-27-91-21; Capital MS&L, Mary
Clark, Anna Mitchell, Phone: +44-20-7307-5330,
anna.mitchell@capitalmsl.com.
