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DSMB Supports Continuation of Phase 3 AGENDA Trial of Genasense(R) in Advanced Melanoma
Date:3/31/2008

Completion of Target Enrollment Expected in Fourth Quarter

BERKELEY HEIGHTS, N.J., March 31 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced that the Data Safety Monitoring Board (DSMB) for AGENDA, a Phase 3 trial of Genasense (oblimersen sodium) Injection, which is the Company's lead oncology product, has recommended that the trial be continued as originally planned after initial review of blinded safety data from the study.

AGENDA is a Phase 3, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from Genta's prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients identified by a biomarker who have not previously received chemotherapy. The co-primary endpoints of AGENDA are progression-free survival and overall survival.

At the end of the first quarter, the trial had accrued approximately 50 patients with approximately 60% of planned investigative sites having been initiated. Countries with sites currently open for enrollment include the U.S., Canada, Australia, France, Germany, Austria, and the Czech Republic. The trial is planned to open at approximately 90 sites worldwide, and most remaining sites are expected to initiate within the next 30 days. Target accrual of 300 patients is expected to complete in the fourth quarter of 2008, with initial data expected shortly thereafter.

"Investigator enthusiasm for AGENDA is quite high, and we are currently recruiting at our expected rate," said Dr. Loretta M. Itri, M.D., Genta's President, Pharmaceutical Development. "We believe the current rate, combin
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SOURCE Genta Incorporated
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