Transgene Receives Positive Scientific Advice from the European Medicines Agency for the Phase IIb/III trial of its Targeted Immunotherapy Product TG4010 for the Treatment of Non-Small Cell Lung Cancer
Parc dInnovation, Illkirch, France, September 1st, 2010 Transgene (Euronext Paris: FR0005175080) today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase IIb/III trial of its immunotherapy product TG4010 for the treatment of advanced non-small cell lung cancer (NSCLC).
Following its review, the EMA has agreed with the design of the proposed pivotal phase IIb/III study intended to be supportive of the Marketing Authorisation Application of TG4010 used in combination with first line therapy, in patients with advanced MUC1 expressing NSCLC and with normal levels of activated Natural Killer (aNK) cells before treatment. The EMA also agreed with the proposed development strategy of the companion tests used to identify this subpopulation of patients.
The study will involve approximately 1,200 patients. Transgene expects to obtain regulatory clearance, to initiate this study, before year end. The final results are expected to become available by the end of 2013.
Philippe Archinard, Chairman and CEO of Transgene stated: "The EMA's positive Scientific Advice for TG4010 in NSCLC represents a major milestone in the clinical development plan of this compound. We are also actively preparing the next steps and look forward to working closely with the FDA in order to further validate the design of this proposed pivotal Phase IIB/III study as part of the Special Protocol Assessment FDA process (SPA).
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