Genta Inc. announced that the company's proposal for a randomized trial of Genasense (oblimersen sodium) Injection in patients with chronic lymphocytic leukaemia (CLL) has completed Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA).

The SPA, which was submitted in December 2005, documents agreements regarding the trial's design and planned analysis. Genta has filed a New Drug Application (NDA) for Genasense plus chemotherapy, which is currently under review by FDA. The NDA has a target action date for a marketing approval decision by October 29, 2006 under the Prescription Drug User Fee Act (PDUFA).

The proposed trial, which will be conducted in symptomatic patients who have not previously received chemotherapy, would randomize patients to receive fludarabine plus rituximab (Rituxan, Genentech, Inc.) with or without Genasense. The pivotal trial in the pending NDA employed a combination of fludarabine plus cyclophosphamide with or without Genasense in patients with relapsed or refractory CLL. The NDA was the subject of a review by FDA's Oncology Drug Advisory Committee (ODAC) on September 6, 2006 and did not receive a majority vote to approve the application.

"We are pleased that FDA had no outstanding issues regarding the design or analysis of this trial, and also with the Agency's agreement that there were no safety issues that precluded the use of Genasense in previously untreated patients," noted Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "While the NDA remains under active review, we will provide Genasense at no cost to CLL patients in response to single-patient IND requests (also known as "compassionate use" requests). We will not make a decision whether to proceed with this new trial until we have had our requested meeting with FDA to review the status of the pending NDA."