Genta disappointed with Phase 3 Trial results of Genasense Print E-mail
By Staff and Wire Reports   
Monday, 23 May 2011 07:55
Genta Incorporated (OTCBB:GNTA) has announced that overall survival for patients treated with its Genasense (oblimersen sodium) Injection plus chemotherapy in AGENDA, the Company's Phase 3 trial of Genasense in patients with advanced melanoma, was not significantly superior compared with patients treated with chemotherapy alone.

"We are keenly disappointed in this result, which terminates our 10-year effort to achieve a clinically meaningful benefit for patients with melanoma," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "In view of these results, we will review the Company's pipeline portfolio and provide further guidance in the near future. Genta is grateful for the tireless dedication of our employees and for the contributions of the many physicians, patients, and families who have worked to advance Genasense for cancer treatment."

Last month, the company had told investors that it expected to release this statement regarding the result for overall survival in May as data collection process for this double-blind trial had not yet been completed.

AGENDA was a randomized, double-blind, placebo-controlled trial of dacarbazine administered with or without Genasense(R) in patients who had not previously received chemotherapy. As defined in a prior randomized trial, AGENDA employed a biomarker to define patients who might maximally benefit from such treatment.

In the trial, median survival was 13.5 months in the Genasense group(R) and 13.1 months in the chemotherapy-only group (P=0.73). The durable response rate (i.e., the proportion of patients who achieved a major objective response that persists at least 6 months) was 10.8% and 7.6%, respectively (P=0.32).

The safety profile of Genasense in AGENDA was consistent with prior studies, as previously released.




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