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Sunesis Pharmaceuticals Provides Year-End Clinical Update on Voreloxin
Date:1/12/2009

reloxin weekly for three weeks, was reported. Eleven patients achieved a complete remission (CR) or complete remission without full platelet recovery (CRp), for an overall remission rate of 38 percent. The 30-day all-cause mortality rate was 17 percent, which compares favorably to standard induction chemotherapy. Data on the median duration of response for patients achieving a CR or CRp in Schedule A is not yet available.

With Schedule B, 72 mg/m2 of voreloxin weekly for two weeks, Sunesis is exploring if the therapeutic index is improved by eliminating the third dose. Early data suggest that Schedule B is better tolerated by patients, while maintaining anti-leukemic activity. New data on the 21 patients on Schedule B reported on at ASH indicate 6 have achieved a CR or CRp, while 2 are awaiting hematologic count recovery. In addition to improved tolerability, the 30-day all-cause mortality rate has been reduced to 5 percent (1 of 21).

Additionally, the company is rapidly accruing relapsed or refractory AML patients in a Phase 1b/2 clinical trial testing voreloxin in combination with cytarabine given by continuous infusion (Schedule A) or by 2 hr IV infusion (Schedule B). At ASH, Sunesis reported that a maximum tolerated dose (MTD) of 80 mg/m2 was established for Schedule A, with 9 CRs or CRps reported in the Phase 1b dose escalation. The Phase 2 portion of this study has now enrolled eight patients with AML in first relapse at the Schedule A MTD and complete remissions have been observed. In addition, Schedule B has completed safety assessment for the first cohort without dose limiting toxicities, and the second cohort is now enrolling at 80 mg/m2 of voreloxin.

"We are extremely pleased by these interim results for both of our AML studies. In the REVEAL-1 study, overall tolerability has improved with the amended dose regimen, while maintaining activity," said Steve Ketchum, Senior Vice President,
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SOURCE Sunesis Pharmaceuticals, Inc.
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