BERKELEY HEIGHTS, N.J., Sept. 15 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced today that the independent Data Monitoring Board (DMB) for AGENDA, a Phase 3 trial of the Company's lead oncology product Genasense(R) (oblimersen sodium) Injection, has completed its review. During its review, the DMB evaluated safety data from the study and conducted an analysis for futility. With more than half of the initially planned number of patients now enrolled, the Board recommended that the trial continue to completion of full enrollment.
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. A total of 300 patients are expected to enroll in AGENDA.
Genta will provide a pooled update of blinded data from AGENDA, compared with data obtained in this biomarker-defined population from the Company's previous Phase 3 trial (see below), at an international scientific meeting, Perspectives in Melanoma XII, that is scheduled for October 2-4, 2008.
"We remain quite pleased with the high investigator enthusiasm for AGENDA," said Dr. Loretta M. Itri, M.D., Genta's President, Pharmaceutical Development. "We currently anticipate that accrual will complete in the first quarter of 2009."
AGENDA employs a biomarker to define those patients who derived maximum
clinical benefit during a large randomized study of DTIC with or without
Genasense, known as study GM301. These patients are characterized by
low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme
|SOURCE Genta Incorporated|
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