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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

tudy of Voreloxin and Cytarabine Indicates Activity of Combination Regimen

Preliminary results were also presented today from Sunesis' ongoing dose-escalating Phase 1b clinical trial evaluating voreloxin in combination with cytarabine, the current standard of care in patients with relapsed and/or refractory AML. The Phase 1b trial is designed to evaluate the safety and tolerability, and to provide a preliminary assessment of anti-leukemic activity, of escalating doses of voreloxin when administered on days one and four with a fixed dose of 400 mg/m2/day of cytarabine given as a continuous infusion for five days. Of twelve evaluable patients in the first three cohorts, three patients have achieved CRs (one at 20 mg/m2 of voreloxin and two at 34 mg/m2 of voreloxin). Six patients were enrolled in cohort 4 (50 mg/m2 of voreloxin), and no dose limiting toxicities have been observed thus far at this dose. Patients are now being enrolled in cohort 5 at 70 mg/m2 of voreloxin. Voreloxin pharmacokinetics have so far been unaffected by the combination with cytarabine.

"We are very pleased by the interim results reported today from our Phase 1b combination study of voreloxin with cytarabine. We look forward to reporting results from this study later in the year, including CR rates at 50 mg/m2 and higher dose levels of voreloxin," continued Dr. Michelson.

These data were presented today in a poster titled "Safety and Efficacy Experience of Voreloxin (formerly SNS-595) in Relapsed/Refractory Acute Leukemia Patients >/= 60 Years Old Compared to <60 Years Old: Results of a Phase 1b Study" (Abstract #0515) at the 13th Congress of the European Hematology Association. A copy of the poster will be available on the Sunesis corporate website at http://www.sunesis.com.

About Voreloxin (formerly SNS-595)

Sunesis' lead compound, voreloxin (formerly SNS-595), is a novel naphthyridine analog, structurally re
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SOURCE Sunesis Pharmaceuticals, Inc.
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3. Sunesis Pharmaceuticals to Present Interim Clinical Data From Voreloxin (Formerly SNS-595) Ovarian Cancer Trial at 44th ASCO Annual Meeting and Acute Myeloid Leukemia Trials at 13th EHA Congress
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