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Sunesis Pharmaceuticals Presents Clinical Trial Data of Voreloxin in Patients with Acute Myeloid Leukemia and Ovarian Cancer at the Chemotherapy Foundation Symposium
Date:11/6/2008

ctivity in the relapsed/refractory AML population supports further clinical development.

Researchers also presented initial data from an ongoing Phase 1b/2 study testing voreloxin in combination with cytarabine. The Phase 1b/2 trial is designed to evaluate safety, pharmacokinetics and 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 11 evaluable patients in the first three cohorts, 3 patients have achieved a complete remission (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 one had complete remission and one had a complete remission without full platelet recovery.

A copy of this presentation entitled "Voreloxin (SNS-595): An Active Agent in AML" is available at http://www.sunesis.com.

A Phase 2 Trial of Voreloxin in Platinum-Resistant Ovarian Cancer

In this ongoing Phase 2 study, 65 women with advanced platinum-resistant ovarian cancer were administered voreloxin at a dose of 48 mg/m2 as a single agent once every three weeks. At this dose, two patients have had a complete response, five have had partial responses and 23 achieved stable disease for 90 days or more. This equates to an overall disease control rate of 46%. Thirty-five women in the Phase 2 study were given 60 mg/m2 once every four weeks. Of the 32 patients evaluable for efficacy at this dose, one patient has had a complete response, two have had partial responses and 20 achieved stable disease thus far.

Voreloxin was also generally well tolerated in platinum-resistant ovarian cancer patients. Grade 3/4 non-hematologic adverse events (greater than or equal to 5%) at the 48 mg/m2 dose were low: fatigue (14%), vomiting (6%) and infections (8%). Low rates of febrile neutropenia occurred in 8%
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SOURCE Sunesis Pharmaceuticals, Inc.
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3. Sunesis Pharmaceuticals to Present Data on Two Product Candidates at the 49th Annual Meeting of the American Society of Hematology
4. Sunesis Pharmaceuticals Reports Positive Interim Data for SNS-595 Single-Agent Activity in Platinum-Resistant Ovarian Cancer
5. Sunesis Pharmaceuticals to Present Non-Clinical Data at the Annual Meeting of the American Association for Cancer Research
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