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This on-going trial is a randomized, open label and controlled studydesigned to assess the efficacy of TG4010 in combination with cisplatin andgemcitabine compared to the chemotherapy regimen alone. The trial completedthe enrolment of 148 patients at the end of May 2007 and was conducted in 27centres located in France, Poland, Germany, and Hungary. The patients hadNSCLC expressing MUC1, either stage IIIB with effusion or stage IV, and hadnot received prior systemic treatment for their advanced disease. Half of thepatients received the combination regimen (TG 4010 vaccine plus chemotherapy)and the other half of the patients received chemotherapy alone.
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The trial confirmed the favourable safety profile of TG4010 whenassociated to chemotherapy: most adverse events observed so far wereconsidered related to chemotherapy as well as to the underlying disease.Hematological toxicity was equivalent in both treatment groups. Most frequentadverse 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 ofTG4010 with the chemotherapy. These results nevertheless remain subject to acentralised review process that is presently on-going.
"We report today encouraging trends on the preliminary results of ourPhase IIb trial with TG4010 in non-small cell lung cancer" said PhilippeArchinard, Chief Executive Officer of Transgene. "We expect to present dataduring the second quarter of this year and final data by the fourth quarterof 2008."
About TG4010 cancer vaccine
TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, apoxvirus that combines distinguishing advantages for an optimized systemicvaccination:
- MVA is a highly attenuated strain which has been tested extensively inhumans as a smallpox vaccine and is known to strongly stimulate the immuneresponse to antigens.
- MUC1 is a major tumor-associated antigen that provides a viable targetfor vaccination.
- TG4010 expresses the entire MUC1 gene sequence and has the potential togenerate an immune response to all antigenic epitopes of MUC1.
- The sequence coding for the cytokine Interleukin 2 (IL2) is included tohelp 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-US_17-05-2005_ASCO_POUMON.pdf (Due to the length of this URL, it may benecessary to copy and paste this hyperlink into your Internet browser's URLaddress field. Remove the space if one exists.)
About Transgene
Transgene is a France-based biopharmaceutical company dedicated to thedevelopment of therapeutic vaccines and immunotherapeutic products inoncology and infectious diseases. The company has one product which hascompleted Phase II trials (TG4001/R3484), two compounds in Phase II trials(TG4010 and TG1042) and one compound in Phase I studies (TG4040). Transgenehas concluded a strategic partnership agreement with Roche for thedevelopment of its TG4001/R3484 therapeutic vaccine to treat HPV-mediateddiseases. Transgene has bio-manufacturing capacities for viral-based vectorsand technologies available for out-licensing. Additional information aboutTransgene is available on the Internet at http://www.transgene.fr.
Cautionary note regarding forward-looking statements
This press release contains forward-
