Genta Incorporated and Aventis announced the availability of Genasense (oblimersen sodium) Injection for use in combination with dacarbazine (DTIC) through an Expanded Access Program (EAP) for eligible patients in the U.S. with advanced melanoma who have not previously received chemotherapy. Genasense in combination with dacarbazine has been granted priority review by the U.S. Food and Drug Administration (FDA) for potential approval for the treatment of advanced melanoma.

Expanded access programs are designed to make investigational agents available at the earliest opportunity for the treatment of patients with diseases for which no comparable or satisfactory alternative drug is available.

Genasense is being made available for use in combination with dacarbazine at certain clinical sites throughout the U.S. for eligible patients with Stage IV and unresectable Stage III melanoma who have not been previously treated with dacarbazine or temozolomide-containing chemotherapy regimens.

Genasense has been studied in this patient population through the largest randomized trial ever conducted for advanced melanoma. In this phase 3 trial, 771 patients who had not previously received chemotherapy were randomized to receive either Genasense plus dacarbazine or dacarbazine alone.

"Advanced melanoma is a devastating disease that is very resistant to treatment," said Dr. Evan Hersh, director, Melanoma Program, Arizona Cancer Center. "Our center participated in the Genasense trial, and we were very encouraged by the results. Genasense may represent a significant step forward in the way in which we treat this disease."

"There has been almost no progress in the treatment of melanoma in the past 30 years," stated Karen Graham, president of The Billy Foundation for Melanoma Research. "A potential new treatment is welcome news and offers hope to the melanoma community."

In this phase 3 clinical trial, when Genasense was combined with dacarbazine, the most frequent serious adverse event occurring in more than 5 per cent of patients was fever (5.9 per cent); the most frequent Grade 3 or 4 adverse events occurring in more than 5 per cent of patients were neutropenia (21.3 per cent), thrombocytopenia (15.6 per cent), leukopenia (7.5 per cent), anemia (7.0 per cent), and nausea (7.0 per cent).