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SOUTH SAN FRANCISCO, Calif., June 13, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced 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 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin, Sunesis' lead product candidate, in patients with first relapsed or refractory acute myeloid leukemia (AML).
"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 R. Craig, MD, PhD, Executive Vice President, Development and Chief Medical Officer of Sunesis. "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."
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial's target enrollment is approximately 675 patients at more than 100 leading sites in the U.S., Canada, Europe, South Korea, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized in a ratio of 1:1 to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. The trial's primary endpoint is overall survival. For more information on the VALOR trial, please visit
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. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory acute myeloid leukemia in combination with cytarabine.