GENTA'S GENASENSE FAILS IN AML TRIAL

Genta has announced preliminary results from a randomized Phase III trial of chemotherapy with or without Genasense (oblimersen sodium) injection that was conducted in older, previously untreated patients with acute myelogenous leukemia (AML). According to the analysis, the trial failed to meet its primary endpoint of overall survival. Further analyses of these data will be submitted for presentation at a scientific meeting. This study was sponsored by the Division of Cancer Treatment and Diagnosis of the National Cancer Institute (NCI) under a cooperative research and development agreement.

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 evaluating its potential to treat various forms of cancer.

In October the company announced that the FDA had extended the review period for the pending new drug application (NDA) for Genasense plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia. The NDA was reviewed at a meeting of the FDA's Oncologic Drug Advisory Committee meeting in September where it failed to receive a majority vote to recommend approval.