Genta Incorporated has restructured certain of its operations to conserve cash and focus on its priority oncology development operations. In March 2008, the company has received notice that its appeal of an adverse decision by the Food and Drug Administration's (FDA) Centre for Drug Evaluation and Research (CDER) regarding its New Drug Application (NDA) for the use of Genasense in patients with chronic lymphocytic leukaemia (CLL) would not be reversed.

While the company is undertaking certain actions recommended by CDER, this decision precludes a commercial launch of Genasense during 2008, and accordingly the company has reduced its workforce by 16 people, or approximately 30 per cent.

"The highest priority for the company is the timely completion of accrual and data readout from Agenda, our ongoing phase III trial of Genasense in patients with advanced melanoma", said Dr Raymond P Warrell, Jr., Genta's chairman and chief executive officer. "Since these products address important patient needs and generate revenue for the company, we will be maintaining our "named-patient" programmes for Genasense and Ganite. However, given the delays in commercialization of our lead product, we have underinvested in our marketed drug, Ganite, and will be seeking buyers for that product. In other actions, we expect to file a complete response to FDA's clinical hold on tesetaxel, our new oral taxane, and we anticipate clinical presentations on both Genasense and G4544 -- an oral compound that reduces calcium loss from bone at the ASCO meeting in the second quarter".

"I am very pleased that Lloyd Sanders has agreed to increase his leadership role in this consolidation as COO by assuming oversight responsibility for information technology, business development, manufacturing operations, and commercial operations. The steps we are taking today will conserve cash, maintain our pace of enrollment into AGENDA, while enabling continued regulatory progress on our pipeline products. We project a one-time expense of $235,000 for severance in the second quarter, and an annualized reduction in payroll expense of approximately $2 million".