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Sunesis Pharmaceuticals' SNS-595 Shows Clinical Activity in Patients With Relapsed or Refractory Acute Leukemias; Data Presented in Oral Session at 49th Annual Meeting of the American Society of Hematology
Date:12/10/2007

damage, was administered on a weekly or twice weekly schedule to patients with relapsed or refractory acute leukemias. Twelve of thirty patients (40 percent) who received doses of SNS-595 of 50 mg/m2 or greater on a weekly dose schedule achieved bone marrow blast reductions to less than five percent, and four of these twelve patients achieved either complete remission (CR), complete remission without platelet recovery (CRp) or complete remission with incomplete recovery of normal hematopoietic blood elements (CRi). In the twice-weekly dosing cohort, anti-leukemic activity was observed among two out of fourteen patients (14 percent) who received doses of 40 mg/m2 or greater, including one complete remission. In both arms of the study, SNS-595's anticancer activity correlated with sustained exposure to drug above a threshold plasma concentration for at least 20 hours per week of active treatment. At the maximum-tolerated-dose, this threshold was exceeded on average in both dosing schedules.

"SNS-595 is a novel chemotherapeutic agent with a distinct mechanism of action that is demonstrating both good tolerability and early signals of promising clinical activity in a group of patients with very advanced acute leukemias," said Dr. Lancet, a principal investigator for the Phase 1 trial. "I look forward to its continued clinical development in AML, both as a single agent and in combination with other cytotoxics."

The Phase 1 clinical trial was designed to evaluate the safety and tolerability of escalating doses of SNS-595 and to establish the maximum-tolerated dose in both treatment schedules. A preliminary assessment of SNS-595's anti-tumor activity as a single agent was a secondary objective of the trial. Overall, SNS-595 was generally well tolerated, with a dose-limiting toxicity of reversible Grade 3 - 4 oral mucositis. A maximum-tolerated dose of 72 mg/m2 once-weekly and 40 mg/m2 twice-weekly was established. SNS-595 exhibited consistent and predictable
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SOURCE Sunesis Pharmaceuticals, Inc.
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