Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advance...( Randomized Double-Blind Study Tar...),Health

Randomized, Double-Blind Study Targets Biomarker-Defined Population

BERKELEY HEIGHTS, N.J., Aug. 21 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced that the first patients have been enrolled in the Company's confirmatory Phase 3 trial of Genasense (oblimersen sodium) Injection in advanced melanoma. The 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 is expected to take approximately 18 months, with initial data expected shortly thereafter.

AGENDA is designed to confirm the safety and efficacy of Genasense when combined with DTIC in patients who have not previously received chemotherapy. Genta's prior Phase 3 trial of this drug combination had shown that maximal benefit occurred in patients with normal baseline LDH, a blood enzyme that strongly correlates with outcome. The AGENDA study is limited to patients whose baseline LDH is less than 0.8 times the upper limit of normal. Analysis of that trial suggested that patients in this group achieved a significantly superior outcome (see table below).

"Genasense plus dacarbazine yielded superior results in a large randomized trial," said Dr. Agop Bedikian, Professor of Medicine at the M.D. Anderson Cancer Center, Houston, TX, who was the lead author on the publication of the previous Genasense trial. "Our center is pleased to have entered the first patient onto this important new study that seeks to extend those initial results using a biomarker t
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SOURCE Genta Incorporated Copyright©2007 PR Newswire.

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