Genta's Genasense misses Ph III endpoint

US drugmaker Genta's Genasense (oblimersen sodium) missed its efficacy endpoint in a Phase III trial in combination with chemotherapy that was conducted in older, previously untreated patients with acute myelogenous leukemia. According to the analysis conducted by the Cancer and Leukemia Group B, the trial failed to meet its primary endpoint of overall survival.

New Jersey-headquartered Genta says that further analyses of these data will be submitted for presentation at an upcoming scientific meeting, noting that this study was sponsored by the Division of Cancer Treatment and Diagnosis of the US National Cancer Institute, under a cooperative R&D deal. Genasense is the company's lead compound from its oligonucleotide program and Genta has submitted a New Drug Application to the US regulator for its use against relapsed or refractory chronic lymphocytic leukemia.