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Genta starts Genasense melanoma combination study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genta has initiated a new clinical study to evaluate its Bcl-2 inhibitor Genasense (oblimersen) in patients with advanced melanoma, the company announces Nov. 29. The trial is the first follow-on study to Genta's Phase III advanced melanoma trial of Genasense plus dacarbazine. The new pilot study will evaluate safety, efficacy and pharmacokinetics of Genasense combined with Abraxis BioScience's Abraxane (paclitaxel protein-bound particles) and Schering-Plough's Temodar (temozolomide). Meanwhile, Genta saw a setback Dec. 8 when preliminary results of a Phase III study of Genasense in acute myeloid leukemia failed to reach the overall survival primary endpoint. The company's NDA for chronic lymphocytic leukemia has a user fee date of Jan. 29 (1Pharmaceutical Approvals Monthly November 2006, In Brief)...

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