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GEN News Highlights : Sep 19, 2006

Survival Impact of Biomarker Identified in Phase III Trial of Melanoma Drug

Genta presented the results of a collaborative study by Genta and the Melanoma Group of the European Organization for the Research and Treatment of Cancer. The results confirmed the strong relationship between patient survival and a biomarker that was prospectively studied in the randomized Phase III trial of Genasense® (oblimersen sodium) injection in patients with advanced melanoma.

Genta says the Genasense data derives from the largest randomized controlled trial ever conducted in patients with advanced melanoma. In this trial, 771 patients were randomly assigned to receive chemotherapy with dacarbazine alone or in combination with Genasense. The results of this trial showed that multiple outcomes, including overall survival, progression-free survival, overall response, and durable response, were strongly associated with blood levels of an enzyme known as LDH, a biomarker that was a prospectively defined stratification factor.