GENTA PUBLISHES FINAL REPORT OF GENASENSE TRIAL

Genta announced that results of the company's Phase III trial of Genasense (oblimersen sodium) Injection in patients with advanced melanoma have been published online in the Journal of Clinical Oncology. The extended follow-up data from this publication form the basis of a marketing authorization application that is currently pending review by the European Medicines Agency (EMEA).

Genasense is a targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma.

The results are based on long-term data derived from the largest randomized, controlled trial that has ever been conducted in patients with advanced melanoma. In this trial, which was conducted at 139 sites in nine countries, 771 patients were randomly assigned to receive chemotherapy with dacarbazine (DTIC) alone or in combination with Genasense. The paper includes data from a prospectively defined analysis that evaluated 24-months of minimum follow-up on all patients.

The FDA's Oncologic Drugs Advisory Committee on Sept. 6 recommended against approving the company's new drug application for Genasense.