Sunesis Pharmaceuticals Announces Initiation Of An Investigator-Sponsored Phase I/II Trial Evaluating Vosaroxin In Myelodysplastic Syndrome

SOUTH SAN FRANCISCO, Calif., Oct. 28, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the initiation of a Phase I/II investigator-sponsored trial of vosaroxin, the company's lead product candidate, in adult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome (MDS). The trial is being conducted at Weill Cornell Medical College and New York-Presbyterian Hospital under the direction of Gail J. Roboz, M.D., Associate Professor of Medicine and Director of the Leukemia Program.

"MDS remains a challenging disease in adult patients with few proven effective therapies," said Dr. Roboz. "As a result, there is an urgent need for new treatments for MDS patients who have progressed after front-line treatment. We look forward to studying vosaroxin in this setting."

The Phase I/II, open-label, dose escalating trial is expected to enroll approximately up to 40 patients with MDS who have previously failed treatment with hypomethylating agent-based therapy. Patient cohorts will initially receive escalating doses of vosaroxin over each 28 day treatment cycle. Once the maximum tolerated dose (MTD) is determined, an expanded evaluation of safety and hematologic response or improvement rate at this dose level will be conducted in additional subjects, so that the total number of subjects exposed to this dose level increases to up to 15 subjects. In addition to MTD and dose limiting toxicity, study endpoints include rate of complete remission, partial remission, hematologic improvement and blood transfusion requirements.

"In our early clinical work, single-agent vosaroxin has demonstrated promising anti-leukemic activity and a favorable tolerability profile in elderly patients," said Adam R. Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis. "Both elements provide a strong rationale for investigating its use as a treatment for MDS.  We look forward to seeing the data collected by the team at Weill Cornell Medical College in this important area of unmet medical need, while we focus our internal resources on the completion of our fully-enrolled pivotal Phase 3 VALOR trial of vosaroxin in first relapsed or refractory AML patients."

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