Genta Updates Progress of its Phase 3 Trial of Genasense(R) in Patients with Advance... ( Clinical Study on Track to Compl...)

Genta Updates Progress of its Phase 3 Trial of Genasense(R) in Patients with Advanced Melanoma

Date:6/24/2008

Clinical Study on Track to Complete Accrual in Fourth Quarter 2008

BERKELEY HEIGHTS, N.J., June 24 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced the presentation of a progress update from an ongoing Phase 3 trial of Genasense(R) (oblimersen sodium) Injection, the Company's lead oncology product, in patients with advanced melanoma. The data were presented at a satellite investigator's meeting held in conjunction with the Adjuvant Melanoma Congress sponsored by the European Association of Dermato-Oncology (EADO) in Marseille, France on June 21, 2008.

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. The trial is being led by the EADO in Europe and by the M.D. Anderson Cancer Center, Houston, TX in the U.S.

To date, more than one-third of the expected total number of patients have now been randomized onto the AGENDA trial. A total of 83 sites in 12 countries have been opened in Europe, the U.S., Canada, and Australia. Clinical characteristics of the first 70 patients accrued to AGENDA (not identified by treatment group) were shown to be similar to the biomarker-defined population accrued in the previous Phase 3 trial of Genasense, known as GM301. The incidence of serious adverse events in AGENDA has been somewhat lower, which probably reflects the routine use of prescribed supportive care for all patients, as well as the double-blind design of AGENDA compared with the open-label design of GM301. Target accrual of 300 patients is expected to complete in the fourth quarter
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