Sunesis Pharmaceuticals Announces Initiation Of An Investigator-Sponsored Trial Evaluating Vosaroxin In Combination With Azacitidine In MDS

SOUTH SAN FRANCISCO, Calif., Dec. 10, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the initiation of an investigator-sponsored trial of vosaroxin in combination with azacitidine in patients with myelodysplastic syndrome (MDS). The trial is being conducted at the Washington University School of Medicine under the direction of Meagan A. Jacoby, M.D., Ph.D., Instructor of Medicine, Division of Oncology.

"Additional therapeutic options are needed for patients with MDS," said Dr. Jacoby. "While azacitidine has been shown to improve survival in patients with high-risk MDS, existing therapies do not produce a remission in the majority of patients and are not curative. Given its clinical profile, we believe that investigation of vosaroxin's activity in high-risk MDS is warranted."

The Phase 1/2, open label, dose-escalation trial will enroll up to approximately 40 patients with MDS who may have received up to three prior cycles of hypomethylating agent-based therapy. Patients will receive vosaroxin (days one and four) and azacitidine (days one through seven) for a maximum of six cycles. This dose escalation study is designed to enroll six patients per cohort in order to determine the maximum tolerated dose (MTD) and dose limiting toxicity of the combination. Other endpoints include best response, safety, tolerability, and event-free, progression-free, disease-free and overall survival. Once the MTD is determined, up to an additional 20 patients will be enrolled, treated and evaluated at that dose level.

"We are pleased that vosaroxin continues to receive a great deal of interest from the oncology community. With the initiation of this trial, vosaroxin is now being studied in three investigator-sponsored trials at leading U.S. medical research centers," said Adam R. Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis. "We recently highlighted encouraging data in difficult-to-treat AML and high-risk MDS patients from a study at the MD Anderson Cancer Center and now look forward to learning more about the use of vosoraxin in MDS in this new study.  Overall, the results of our IST studies will provide us with valuable clinical data and a greater understanding of vosaroxin's potential as a new treatment option in MDS, as our pivotal Phase 3 VALOR trial in acute myeloid leukemia reaches completion in 2014."

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