Genta to initiate new Ph III of Genasense

New Jersey, USA-based Genta Inc says it will conduct a new randomized controlled Phase III trial of its lead anticancer product, Genasense (oblimersen sodium) injection, in patients with advanced melanoma. The company has sought scientific advice on final aspects of the trial design from regulatory authorities in Europe and the USA. It is actively recruiting experienced investigative sites in Europe, Australia and North and South America, and expects to initiate patient enrollment during the summer of 2007.

The trial is designed to expand evidence for the safety and efficacy of Genasense combined with dacarbazine for patients who have not previously been treated with chemotherapy. It will prospectively target patients using a biomarker that identified patients who derived maximal benefit in a preceding study of the drug, including significant increases in overall and progression-free s.urvival. Genta expects to enroll approximately 300 subjects in this trial. Genasense in melanoma has been designated an Orphan Drug in Australia and the USA, and the drug has fast-track designation in the latter country.