Genta, a biopharmaceutical company, has completed patient enrollment in Agenda, a Phase III trial of Genasense injection in patients with advanced melanoma. Final accrual totaled 315 subjects.
Agenda is a Phase III, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma.
The study was designed to confirm certain safety and efficacy results obtained in a prior randomized trial of Genasense combined with dacarbazine in patients who have not previously received chemotherapy. Agenda employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. These patients are characterized by low-normal levels of lactate dehydrogenase, a tumor-derived enzyme that is readily detected in blood.
Raymond Warrell, Jr, chief executive officer of Genta, said: Completion of this trial represents a major milestone for our company.We currently project that the final assessment of progression-free survival will be analyzed approximately six months after the last patient has been enrolled. If positive, we plan discussions with global regulatory agencies regarding submissions for marketing approval based on this result coupled with our extensive prior data.