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Sunesis Announces Presentation Of Positive Results From Ongoing MD Anderson-Sponsored Trial Of Vosaroxin In AML And High-Risk MDS

Stocks in this article: SNSS

Data Presented at AACR 2014 Annual Meeting Company to Host Conference Call Today at 8:00 AM Pacific Time

SOUTH SAN FRANCISCO, Calif., April 8, 2014 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the presentation of results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The results will be presented today at the Phase II/III Clinical Trials Poster Session of the American Association for Cancer Research Annual Meeting 2014 (AACR) in San Diego, California. The poster (Poster #7, Hall A-E, Poster Section 38) is titled "Phase I/II study of vosaroxin and decitabine in older patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)."

The Phase 1b/2 trial is expected to enroll up to a combined total of approximately 70 patients. As previously announced, the Phase 2 cohort of the Phase 1b/2 was initiated in October 2013, following successful completion of a Phase 1b open-label, single-arm dose optimization phase.  Patients in the ongoing trial are being followed for rate of response, leukemia-free survival, overall survival and safety.  To date, the combination of vosaroxin and decitabine has been found to be effective and well tolerated in older patients with AML and high-risk MDS. Twenty four patients are evaluable for response; 9 (38%) achieved complete response (CR), 5 (21%) achieved CR with incomplete platelet recovery (CRp), and 2 (8%) achieved CR with incomplete peripheral blood count recovery (CRi), for an overall response rate of 67%. The main grade ≥ 3 toxicity was mucositis in 6 (6/29, 21%) patients. No patients died during the initial 30-day induction period. Enrollment in the trial is ongoing.

"The treatment of older patients with AML or high-risk MDS presents particular challenges, including many patients not tolerating or responding to existing therapies," said Farhad Ravandi, M.D., Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center, and a study investigator. "Emerging outcomes from this trial suggest that vosaroxin and decitabine hold meaningful promise as a potential new combination treatment option for this population. The high number of complete remissions with good tolerability are highly encouraging and make this trial a designated priority for our center."

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