Sunesis Pharma Closes Enrollment In Phase 3 Valor Trial Of Vosaroxin In AML

(RTTNews) - Sunesis Pharmaceuticals Inc. (SNSS) announced that it completed enrollment in its pivotal, Phase 3 VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory acute myeloid leukemia or AML.

According to the company, enrollment of 712 patients in the randomized, double-blind, placebo-controlled trial was achieved on schedule. Unblinding of the trial is expected in the first half of 2014 after reaching 562 events and locking the final study database.

VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is being conducted at more than 100 leading sites in the U.S., Canada, Europe, Australia, New Zealand and South Korea. Patients 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.

The company stated that both the U.S. Food and Drug Administration or 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 AML in combination with cytarabine.