Genta Incorporated has announced that the Company will conduct a new randomized controlled Phase 3 trial of its lead anticancer product, Genasense (oblimersen sodium) Injection, in patients with advanced melanoma.
The Company has sought scientific advice on final aspects of the trial design from regulatory authorities in Europe and the U.S. The Company is actively recruiting experienced investigative sites in Europe, Australia, and North and South America, and expects to initiate patient enrollment during the summer of 2007.
The trial is designed to expand evidence for the safety and efficacy of Genasense combined with dacarbazine for patients who have not previously been treated with chemotherapy. The study will prospectively target patients using a biomarker that identified patients who derived maximal benefit in a preceding trial of Genasense, including significant increases in overall and progression-free survival. Genta expects to enroll approximately 300 subjects in this trial. Genasense in melanoma has been designated an Orphan Drug in Australia and the U.S., and the drug has Fast Track designation in the U.S.
"As the lead investigative site in the prior trial, we were highly gratified by seeing results that exceeded those from any other randomized study in patients with advanced melanoma," commented Dr. Agop Y. Bedikian, Professor of Medicine, M.D. Anderson Cancer Center. "We are very pleased to participate in this new trial of Genasense combined with chemotherapy in a biomarker-targeted population."
"The announcement of this trial reaffirms our long-standing commitment to patients afflicted with advanced melanoma," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "The existing Genasense data derive from the largest study ever conducted in this condition. Use of a standard biomarker (serum lactate dehydrogenase [LDH]) to target specific patients should facilitate completion of this study in a considerably smaller population, and if positive, worldwide regulatory submissions."
"At the Melanoma Research Foundation, our mission is to support research that discovers and rapidly translates effective treatments for patients with melanoma," commented Linda Pilkington, Executive Director. "Advanced melanoma is a deadly disease with no satisfactory treatment options available for patients. We are extremely supportive of this new trial that offers the potential to benefit patients."
About Genasense in Advanced Melanoma
Genasense, Genta's lead anticancer drug, is a novel 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. In its initial trial, Genta performed the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. A summary of the long-term follow up data from that study, on which the design of the new trial is based, appears below.
Efficacy
In this trial, 771 patients from 139 sites in 9 countries 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. Unless otherwise noted, these results were based on an intent-to- treat analysis: