Independent Data Monitoring Board Recommends Continuation To Completion Of Genta's Phase 3 Trial Of Genasense(R) In Advanced Melanoma

Main Category: Melanoma / Skin Cancer
Also Included In: Clinical Trials / Drug Trials;  Dermatology
Article Date: 22 May 2009 - 3:00 PDT

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Genta Incorporated (OTCBB:GNTA.OB) announced that the independent Data Monitoring Board (DMB) for AGENDA, a randomized Phase 3 trial of Genasense® in patients with advanced melanoma, has informed the Company that the study has passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion.

Coincident with this recommendation, Genta has submitted an "intent-to-file" notice via the centralized procedure to the European Medicines Agency (EMEA), along with a request for assignment of rapporteurs. Such notice is required prior to submission of a Marketing Authorization Application (MAA).

"Futility analyses after completing accrual have been occasions for failure of two other Phase 3 melanoma drugs earlier this year," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "Having announced enrollment completion last month, we are greatly pleased with this report from the DMB for AGENDA. The next milestone is release of final data on progression-free survival (PFS), which is expected in the 4th quarter of this year. If positive, we expect our regulatory applications for Genasense will be based on statistically significant and clinically meaningful improvements in PFS."

AGENDA is a randomized double-blind trial in 315 patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from a previous randomized trial of Genasense combined with dacarbazine in patients who have not previously received chemotherapy. AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. These patients are characterized by low-normal levels of LDH, a tumor-derived enzyme that is readily detected in blood. In large trials like AGENDA, one or more analyses for "futility" are commonly conducted by an independent committee to determine whether there is no longer a reasonable chance that a trial will achieve its major endpoints. AGENDA has co-primary endpoints of PFS and overall survival (OS), and subsequent futility analyses for OS are planned if the PFS endpoint is achieved. AGENDA is intended to support global registration of Genasense for patients with advanced melanoma.

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 to evaluate its potential to treat various forms of cancer.

Source
Genta

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