In the first stage of the trial, a group of 13 patients with relapsing CBCL will be enrolled at centers in the US, France and Switzerland. If the results are positive, a second group of 28 patients will be recruited.
The primary objective of the study is to evaluate the efficacy of a four-month treatment with the drug after standard first line treatments. Patients will receive injections of TG 1042 to induce an anti-tumor immune response. Clinical endpoints are regression and disappearance of lesions, safety and quality of life.
Philippe Archinard, CEO of Transgene, said: “We have strong hopes that, given the increasing need for efficient treatment modalities in this orphan indication, positive results in this trial could lead to regulatory approval in 2009 for a market launch, which would make TG 1042 Transgene's first product to be commercialized.”