Genta Incorporated and Aventis announced results from their Phase 3 clinical study of Genasense (oblimersen sodium) plus chemotherapy in patients with malignant melanoma. In conjunction with these results, the first portion of the New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) for Genasense in this indication.

The Phase 3 trial enrolled patients at 140 sites from 12 different countries. A total of 771 chemotherapy naove patients were randomly assigned to receive dacarbazine (a standard chemotherapy drug) alone or in combination with Genasense. The primary endpoint of this trial was to compare the overall survival between the two treatment arms. Secondary endpoints included comparative analyses of progression-free survival and tumor response.

"Metastatic melanoma is one of the most devastating forms of cancer," said Loretta M. Itri, MD Genta's President, Pharmaceutical Development, and Chief Medical Officer. "These results have been observed in a disease that is notoriously unresponsive to standard therapy and for which no approved drug has shown a survival advantage. We believe the current data support the NDA submission we have initiated using provisions granted under the "Fast Track" designation for Genasense."

"One of our primary goals at Aventis is to deliver innovative products that help patients with cancer live longer with a better quality of life. Today's promising data may lead to an important advance in targeted therapies for patients with advanced malignant melanoma," said Frank Douglas, Head of Drug Innovation and Approval, and Member of the Board of Management at Aventis. "Our collaboration with Genta to develop and co-market Genasense underscores our commitment to develop breakthrough late-stage compounds that have significant benefit for patients as well as commercial potential."