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Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
Date:10/17/2007

Decision Facilitates European Trial Opening in 13 New Sites

BERKELEY HEIGHTS, N.J., Oct. 17 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced that the French Health Products Safety Agency ("AFSSAPS") has granted authorization to open the Company's Phase 3 trial of Genasense(R) (oblimersen sodium) Injection, its lead anticancer compound, in patients with advanced melanoma. This authorization enables the opening of approximately 13 new investigative sites over the next 2-4 weeks.

Genta's Phase 3 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 currently expected to complete in the fourth quarter of 2008.

About Genasense

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. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodi
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SOURCE Genta Incorporated
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