Genta revises Genasense Special Protocol Assessment, review not completed

By Elaine Rigoli

Tampa, Fla., Aug. 18 - The Food and Drug Administration has not yet completed its review of Genta, Inc.'s proposal for a confirmatory trial of Genasense (oblimersen sodium) injection in patients with chronic lymphocytic leukemia.

The request for a Special Protocol Assessment was submitted in December 2005.

Genta said it has revised its proposal to fully address all issues that had been identified by the FDA and is working to clarify any issues that may remain outstanding prior to the start of the trial.

Genta is a biopharmaceutical company based in Berkeley Heights, N.J.

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