Sapacitabine Phase 1 Data Published In Acute Leukemia And Myelodysplastic Syndromes
December 1, 2009 (FinancialWire) — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) (NASDAQ: CYCCP) announced publication in the Journal of Clinical Oncology of a Phase 1 study evaluating clinical and pharmacokinetic effects of sapacitabine, an orally available nucleoside analog, in 47 patients with refractory or relapsed acute leukemias and myelodysplastic syndromes .
The study was led by Hagop Kantarjian, MD and colleagues at The University of Texas M. D. Anderson Cancer Center, Houston, Texas.
The objective of the study was to define the dose-limiting toxicities and maximum-tolerated dose of sapacitabine given by mouth twice a day for either 7 days every three to four weeks or 3 days for two weeks every three to four weeks. The dose-limiting toxicities with both schedules were gastrointestinal. Maximum-tolerated doses were 375 mg twice a day in the 7-day and 425 mg twice a day in the 3-day schedule. Median age was 65 years (range 35-90). Approximately 68% of patients had received two or more salvage therapies. Responses were observed in 13 patients with acute myeloid leukemia or MDS of which four were complete remissions or CRs, two were complete remissions with incomplete platelet count recovery or CRps and seven were marrow complete responses or CRis. In addition, twenty patients had at least 1-log reduction of peripheral blasts and/or at least 50% reduction of marrow blasts . The estimated 4-week mortality for all patients was 4%.
The data were published ahead of print in the online edition of the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2009.25.0209).
One-year survival data from the Phase 2 AML study stratum and interim response data from the Phase 2 MDS stratum will be reported at the upcoming meeting of the American Society of Hematology this coming Saturday.
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