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

, we see a clear opportunity for this drug in the first-line treatment of older patients who may not benefit from standard induction therapy," said Daniel C. Adelman, M.D., Senior Vice President, Development and Chief Medical Officer of Sunesis. "Treatment options for elderly AML patients are extremely limited. If the data from this trial indicate clear clinical benefit, Sunesis could initiate a pivotal trial in this highly underserved patient population. We expect to present interim data from this trial at a medical conference toward the end of this year."

Sunesis previously reported promising results from its Phase 1 single agent dose-escalation study of voreloxin in relapsed or refractory AML patients. In that trial, 13 of 30 patients (43 percent) who received doses of voreloxin of 50 mg/m2 or greater on a weekly dose schedule achieved bone marrow blast reductions to less than five percent, and five of those 13 achieved either CR, CRp or complete remission with incomplete recovery of normal hematopoietic blood elements. Voreloxin was generally well tolerated, with a dose-limiting toxicity of reversible oral mucositis. A maximum- tolerated weekly dose of 72 mg/m2 was established.

Sunesis also announced today that voreloxin has been accepted as the nonproprietary name for SNS-595 by the United States Adopted Names (USAN) Council, in consultation with the World Health Organization (WHO) International Nonproprietary Names Expert Committee. Although voreloxin has been officially accepted by the USAN Council, the official adoption date has been set for May 28, 2008. The USAN Council serves health professionals in the United States by selecting simple, informative, and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships to ensure that drug information is communicated accurately and unambiguously. The USAN Council aims for global standardization and unification of
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SOURCE Sunesis Pharmaceuticals, Inc.
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