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1-Year Survival Rate of Circa 30% Reported in Two Out of Three Arms
BERKELEY HEIGHTS, NJ, USA | October 28, 2009 | Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC - News) (Nasdaq:CYCCP - News) announced today topline survival data for the primary endpoint of the Phase 2 study of sapacitabine as a treatment for elderly patients aged 70 or older with either newly diagnosed acute myeloid leukemia (AML) or AML in first relapse. The study was a three-arm randomized trial evaluating three dosing schedules of sapacitabine. The primary endpoint of 1-year survival is approximately 30% each on two out of the three schedules tested. Details of the results from this study will be presented at an upcoming medical conference.
"We are pleased to report such encouraging survival data from our Phase 2 study. The data provide a strong rationale supporting the continued development of this novel agent with a differentiated mechanism of action," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are currently working with the FDA to design a Phase 3 registration study for sapacitabine in patients with hematological malignancies. We are concentrating our efforts on advancing sapacitabine into late stage development. In addition we are exploring its potential in solid tumors both as a single agent and in combinations. If Phase 3 trials are successful, sapacitabine could emerge as the first oral drug for the treatment of AML and MDS."
Survival in elderly patients aged 70 or older with newly diagnosed AML remains poor. A recent, randomized study comparing tipifarnib, an investigational drug with a different mechanism to sapacitabine, with best supportive care in this population reported 1-year survival of 15% for the tipifarnib arm and 18% for the best supportive care arm (Harousseau JL, et al, Blood, 2009 01:19:8093).
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a diversified biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. Sapacitabine, a cell cycle modulating nucleoside analog, is in Phase 2 studies for the treatment of acute myeloid leukemia in the elderly, myelodysplastic syndromes and lung cancer and in Phase 1 in combination with seliciclib. Seliciclib, a CDK (cyclin dependent kinase) inhibitor, is in Phase 2 for the treatment of lung and nasopharyngeal cancer. CYC116, an Aurora kinase and VEGFR2 inhibitor, is in Phase 1 in patients with solid tumors. Cyclacel's ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair(R) Cream for radiation dermatitis, Numoisyn(R) Liquid and Numoisyn(R) Lozenges for xerostomia. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a portfolio of commercial products and a development pipeline of novel drug candidates. Please visit www.cyclacel.com for additional information.
SOURCE: Cyclacel Pharmaceuticals, Inc. |
