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SNSS - Sunesis Presents Positive Phase 2 Clinical Data of Voreloxin in Acute Myeloid Leukemia at the American Society of Hematology 2009 Annual Meeting

Conference Call Scheduled for December 8 at 2:00 PM EST to Discuss ASH Data Presentations

SOUTH SAN FRANCISCO, CA--(Marketwire - 12/07/09) - Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS - News) today announced positive data from two Phase 2 clinical trials of the Company's lead drug candidate, voreloxin. The results highlight voreloxin's strong efficacy and safety profile when used as a single agent or in combination with chemotherapy in patients with difficult to treat acute myeloid leukemia (AML). The trial results were presented at the 51st American Society Hematology (ASH) Annual Meeting in New Orleans, LA. The presentations are available on the Sunesis website at www.sunesis.com.

"These results provide us with the efficacy and safety data to move voreloxin forward into pivotal testing," said Steven Ketchum, Ph.D., Senior Vice President of Research and Development at Sunesis. "Trial results show that the high rates of remission observed in both trials have translated into durable effects with meaningful preliminary overall survival results. With an anticipated median survival of three and a half to six months on currently available therapies, primary refractory and first relapse AML patients are particularly in desperate need of more effective treatment options. We look forward to discussing these data with the FDA in our End-of-Phase 2 meeting scheduled for the first quarter of 2010."

Phase 1b/2 Clinical Trial of Voreloxin in Combination with Cytarabine in Relapsed/Refractory (Abstract No. 645)

In an oral presentation, Jeffrey Lancet, M.D., Associate Member, Section Chief - Leukemia, Department of Hematologic Malignancies, at the H. Lee Moffitt Cancer Center & Research Institute and a clinical trial investigator, presented data from a Phase 1b/2 clinical trial testing voreloxin in combination with cytarabine, a widely used chemotherapy, in patients with relapsed or refractory AML. The trial is designed to evaluate the safety, pharmacokinetics and anti-leukemic activity of escalating doses of voreloxin when administered in combination with cytarabine given either as continuous infusion or as a two hour IV infusion. To date, 66 patients have been treated in the expansion Phase 2 populations of the trial, which includes primary refractory and first relapse AML patients. Of these, 64 patients were evaluable for efficacy outcomes.

Among evaluable first relapse (n=36) and primary refractory patients (n=28), preliminary median overall survival is 7.8 months and the remission rate is 31% (complete remission [CR] 27%, complete remission without full platelet recovery [CRp] 2% and complete remission with incomplete recovery [CRi] 2%). Historical median overall survival data in primary refractory and first relapse patients on currently available chemotherapies range from 3.4 to 5.9 months(1) (2).
Voreloxin in combination with either bolus or continuous infusion cytarabine was generally well-tolerated. Infection-related toxicities were the most common Grade 3 or higher non-hematologic adverse events. In addition, Grade 3 or higher oral mucositis was observed.
All-cause mortality among these patients was 1% at 30 days and 8% at 60 days.
A recommended pivotal dose-regimen of voreloxin used in combination with cytarabine has been identified.
"Voreloxin has induced remissions in difficult to treat relapsed, primary refractory and relapsed/refractory AML patients," said Dr. Lancet. "Voreloxin used in combination with cytarabine has demonstrated meaningful anti-leukemic activity with an acceptable tolerability profile in these difficult-to-treat patients."

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