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Sunesis Pharmaceuticals Announces Presentation of Voreloxin Clinical Data in Patients with Acute Myeloid Leukemia at the 50th Annual Meeting of the American Society of Hematology
Date:12/7/2008

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Phase 1b/2 Study of Voreloxin in Combination with Cytarabine in Relapsed/Refractory AML

Researchers also presented interim data from an ongoing Phase 1b/2 clinical trial testing voreloxin in combination with cytarabine. The Phase 1b/2 trial is designed to evaluate the safety, pharmacokinetics and anti-leukemic activity of escalating doses of voreloxin when administered on days one and four with a fixed dose of cytarabine given either as a continuous infusion (Schedule A) or as a daily IV bolus (Schedule B) for five days.

To date, 45 patients have been treated in Schedule A and preliminary data is available for 38 patients in the dose escalation portion of the study. Nine of these 38 patients have achieved a CR or CRp in voreloxin dose cohorts ranging from 20 to 90 mg/m(2). Complete remissions have been observed in both relapsed and in treatment refractory AML patients. Schedule A has also been generally well tolerated with an acceptable safety profile in this heavily pretreated population. A maximum tolerated dose (MTD) of 80 mg/m(2) of voreloxin was established for Schedule A, and AML patients in first relapse are now being enrolled at the MTD in the Phase 2 portion of this study.

Single agent cytarabine is the current treatment standard for relapsed AML patients dosed across a range of different dose levels administered by either bolus infusion or 24 hour continuous infusion with typical remission rates of approximately 20 percent. Schedule B was recently opened for enrollment with a starting dose of voreloxin at 70 mg/m(2) on days one and four. The first cohort of patients has been fully enrolled in Schedule B.

"Voreloxin has demonstrated anti-leukemic activity when administered in combination with cytarabine," said Judith E. Karp, M.D., Director, Adult Leukemia Program at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University and an in
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SOURCE Sunesis Pharmaceuticals, Inc.
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