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DSMB Recommends Increase Following Single, Pre-Planned Interim Efficacy and Safety Analysis of VALOR; Enrollment Completion Expected in 2013 DSMB Recommendation Triggers $25.0 Million Investment in Sunesis from Royalty Pharma Sunesis to Host Conference Call Today at 9:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., Sept. 11, 2012 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that it will implement a one-time, 225-patient sample size increase to its Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia (AML), bringing target enrollment to 675 patients. This is in response to the recommendation of the trial's independent Data and Safety Monitoring Board (DSMB) following their completion yesterday of a single, pre-planned interim analysis of unblinded efficacy and safety data sets from VALOR.
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in patients with first relapsed or refractory AML. The pre-planned sample size increase of 225 additional patients is designed to maintain adequate statistical power over a broader range of survival outcomes. With the revised target sample size of 675 patients, Sunesis anticipates full enrollment of VALOR in 2013, with unblinding of the trial expected in the first half of 2014 upon reaching 562 events and final database lock. The DSMB recommendation also triggers Royalty Pharma's obligation to invest $25.0 million in Sunesis.