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Sunesis Pharmaceuticals Completes Enrollment In Phase 3 VALOR Trial Of Vosaroxin In AML

SOUTH SAN FRANCISCO, Calif., Sept. 25, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that enrollment in the company's pivotal, Phase 3 VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory acute myeloid leukemia (AML) is now complete. 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.

Sunesis Pharmaceuticals, Inc. Logo
VALOR Logo

"Strong investigator support for VALOR from across our more than 100 sites worldwide has allowed us to finish enrolling VALOR, the largest-ever company-sponsored trial in first relapsed/refractory AML, on schedule," said Adam R. Craig, MD, PhD, Executive Vice President, Development and Chief Medical Officer of Sunesis. "With over 700 patients enrolled, VALOR is well powered to demonstrate a clinically meaningful improvement in overall survival, the study's primary endpoint. We look forward to top-line results in the first half of 2014 and, with a positive outcome, to seeing vosaroxin change the global standard of care in this important area of unmet medical need."

The VALOR study was designed around a promising Phase 2 study of vosaroxin in combination with cytarabine in patients with relapsed or refractory AML. The data demonstrated a balance of improved remission rates translating into long leukemia-free survival – including the opportunity to bridge to potentially curative bone marrow transplants – and low induction mortality. Across all past and ongoing studies, more than 700 AML patients have been treated with vosaroxin.

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