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Sunesis Pharmaceuticals, Inc. (SNSS) Provides Update Concerning Phase 2 Clinical Trials for Vosaroxin in AML

Today before the opening bell, Sunesis Pharmaceuticals, Inc. announced positive data from Phase 2 clinical trials of the company’s lead drug candidate, vosaroxin, in combination with cytarabine, a widely used chemotherapy, in relapsed/refractory acute myeloid leukemia (AML) and as a single agent in frontline elderly AML. The data were presented today by Robert Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, at the Chemotherapy Foundation Symposium XXVIII in New York City. The presentation is available to the public on the Sunesis website at

For the fully enrolled relapsed/refractory AML study, a total of 69 patients with first relapse or primary refractory AML have been treated at doses of 80 to 90 mg/m(2) of vosaroxin, in combination with bolus or continuous infusion cytarabine. As demonstrated previously at the American Society of Clinical Oncology (ASCO) Annual Meeting, vosaroxin achieved clinically meaningful complete remission rates balanced with low all-cause early mortality. Preliminary leukemia free survival, measured as time from complete remission to relapse or death, is now 14.4 months (440 days). Median overall survival was 7.1 months, with 14 patients continuing in survival follow up well beyond this median.

These updated clinical findings further support the company’s plan to initiate the VALOR trial, a multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of vosaroxin in combination with cytarabine in a relapsed/refractory AML patient population anticipated to begin before the end of this year.

“The successful treatment of relapsed or refractory AML requires a durable complete remission and low all-cause early mortality with the ultimate goal of getting the patient to transplant, a combination of outcomes observed in this study,” commented Dr. Stuart, a clinical study investigator for the trial and member of the VALOR trial steering committee. “Particularly noteworthy is the long leukemia free survival seen among patients who had a complete remission. These mature data provide encouraging evidence of clinically meaningful benefit for this novel combination in patients with limited treatment options. I hope this benefit will be confirmed in the upcoming VALOR trial which is rigorously designed to demonstrate a clinically meaningful survival advantage over a current standard of care.”

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