Sunesis Pharma's VALOR trial of vosaroxin should continue with no change, says DSMB

Sunesis Pharmaceuticals (Nasdaq: SNSS) says that the independent Data and Safety Monitoring Board (DSMB) for the VALOR trial has completed its latest periodic safety review and recommended that the trial continue as planned without changes to study conduct.

The VALOR trial is a Phase III, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin, Sunesis' lead product candidate, in patients with first relapsed or refractory acute myeloid leukemia (AML). Vosaroxin is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer.

"The DSMB recommendation to continue VALOR is an important milestone, and affirms our confidence in VALOR, the largest industry-sponsored trial undertaken in this disease setting, and in vosaroxin, a drug with significant potential in the treatment of AML," said Adam Craig, executive vice president, development, and chief medical officer of Sunesis, adding: "With this safety review behind us, we now look ahead to completion of enrollment, expected in 2013, then the unblinding of VALOR, which is expected to occur in the first half of 2014."