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Sunesis Pharmaceuticals Initiates Phase 2 Clinical Trial of Voreloxin (SNS-595) in Acute Myeloid Leukemia
Date:5/21/2008

SOUTH SAN FRANCISCO, Calif., May 21 /PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced the initiation of the REVEAL-1 (Response Evaluation of Voreloxin in Elderly AML) Phase 2 clinical trial of voreloxin (also known as SNS-595), the company's lead anti-cancer therapeutic. The REVEAL-1 trial is being conducted in previously untreated elderly patients with acute myeloid leukemia (AML) who are unlikely to benefit from standard induction therapy. The first patient was enrolled and treated at the Indiana University Melvin and Bren Simon Cancer Center under the care of Larry D. Cripe, M.D., Associate Professor, Department of Medicine, Division of Hematology/Oncology at the Indiana University School of Medicine.

The primary objective of the REVEAL-1 trial is to evaluate voreloxin's anti-leukemic activity as a single agent, measured as either complete remission (CR) or complete remission without full platelet recovery (CRp). The study will also measure the duration of these responses. In order to qualify for the trial, patients must be at least age 60 with previously untreated AML and satisfy at least one of the following factors: poor performance status (PS 2); intermediate or unfavorable cytogenetics; prior antecedent hematologic disorder; or age greater than or equal to 70 years. Patients enrolled in the trial will receive three weekly doses of 72 mg/m2 of voreloxin in a treatment cycle. Approximately 55 patients will be enrolled in the open-label, multi-center REVEAL-1 trial.

"We are pleased to move our voreloxin program forward in AML with this Phase 2 trial. Based on the clinical activity and tolerability profiles observed in our Phase 1 trial of voreloxin in relapsed/refractory AML patients
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SOURCE Sunesis Pharmaceuticals, Inc.
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