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Sunesis Pharmaceuticals Presents Data from Clinical Trials of Voreloxin (formerly SNS-595) in Patients with Acute Myeloid Leukemia at the 13th Congress of the European Hematology Association
Date:6/16/2008

nger patients. In the Phase 1 trial, voreloxin was administered on a weekly or twice-weekly schedule and patient demographics were similar between the two treatment schedules. Six patients, including four age 60 or older and two younger than age 60, achieved complete remission (CR) or complete remission without platelet recovery (CRp) or complete remission with incomplete recovery of hematopoeitic elements (CRi) when voreloxin was administered at doses of 50 mg/m2 or greater weekly or 40 mg/m2 twice-weekly. Duration of complete remissions (CR or CRp) was reported. Remissions of up to seven months have been observed thus far, with two patients undergoing reinduction with voreloxin following relapse.

Sixty-eight patients were evaluable for safety, with 42 patients ranging in age from 60-85 years old and 26 patients age 21-59 years. Voreloxin was generally well tolerated in both the older and younger patient subgroups with similar incidence of Grade 3-4 adverse events. The dose-limiting toxicity was reversible oral mucositis, and a maximum-tolerated dose of 72 mg/m2 once-weekly and 40 mg/m2 twice-weekly was established. Researchers also reported that voreloxin pharmacokinetics were not influenced by age.

"AML is primarily a disease of the elderly and the medical need for new agents that can be tolerated by older patients remains unmet. Results from our comparative analysis demonstrate that voreloxin is generally well tolerated and achieves anti-leukemic activity among older, advanced AML patients, supporting our strategy for progressing the clinical development of voreloxin in this indication," said Glenn Michelson, M.D., Vice President, Clinical Strategy at Sunesis. "Sunesis recently initiated the Phase 2 REVEAL-1 (Response Evaluation of Voreloxin in Elderly AML) clinical trial to evaluate voreloxin in newly diagnosed AML in elderly patients. We hope to present initial data from the REVEAL-1 trial later this year."

Preliminary Data from Phase 1b S
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SOURCE Sunesis Pharmaceuticals, Inc.
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