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news.Genta Incorporated has announced that the French Health Products Safety Agency has granted authorization to open the company's Phase III trial of Genasense injection, its lead anticancer compound, in patients with advanced melanoma.
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Genta’s Phase III trial, known as Agenda, is a randomized, double-blind, placebo-controlled study in which patients are randomly assigned to receive Genasense plus dacarbazine (DTIC) or DTIC alone.
Agenda will accrue approximately 300 patients and will be conducted at approximately 100 sites worldwide, including North America, Europe and Australia. Accrual, which is currently ongoing, is expected to complete in the Q4 of 2008.
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment.