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FDA Indicates That Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
Date:3/17/2008

eutical Development, and Chief Medical Officer. "Our approach mirrors our strategy for Genasense in melanoma in which a smaller Phase 3 trial, expected to complete accrual later this year, seeks to confirm efficacy by focusing on patients who derived maximum benefit in a large randomized trial. In parallel with collection and analysis of existing data in CLL, Genta has developed a new clinical trial, and the Company will file its draft protocol seeking formal Scientific Advice at the May meeting of the European Medicines Agency (EMEA). Genta greatly appreciates the professional and collaborative communications with FDA during this process, and we look forward to working closely with FDA in addressing their recommended options for securing the confirmatory data."

Proposed Confirmatory Trial of Genasense in CLL

The proposed protocol, based on results obtained during the previous trial, is a randomized controlled trial at first or second relapse in patients who are "non-refractory". All patients will receive fludarabine plus cyclophosphamide (Flu/Cy) - an accepted standard of care - and they will be randomly assigned to receive Genasense or no additional therapy. The trial will seek to confirm that the addition of Genasense increases complete responses (CR) in patients who receive Flu/Cy chemotherapy.

In the preceding Phase 3 trial, 241 patients with relapsed or refractory CLL were randomly assigned to receive Flu/Cy with or without Genasense. This study achieved its primary endpoint - an increase in the proportion of patients who achieved CR (17% vs. 7%; P=0.025). By definition, CR represents the complete elimination of all clinical signs of leukemia, combined with the elimination of leukemia-related symptoms. The duration of CR was also significantly longer for patients treated with Genasense (i.e., median not yet reached but exceeding 36 months in the Genasense group compared with 22 months for the Flu/Cy-only group).

In patients predefin
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SOURCE Genta Incorporated
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