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Ambit and Astellas Announce Results From Multiple Quizartinib Presentations at the 53rd Annual Meeting of the American Hematology Society
Date:12/13/2011

SAN DIEGO, Dec. 13, 2011 /PRNewswire/ -- Astellas Pharma Inc. (Tokyo: 4503, Astellas) and Ambit Biosciences Corporation announced today that updated results from an interim analysis of a Phase 2 study of quizartinib (formerly AC220) in acute myeloid leukemia (AML) were presented at the 53rd Annual Meeting of the American Society of Hematology (ASH) in San Diego, California.  Data were also presented from two additional posters: one evaluating the pharmacodynamic effects of quizartinib in a pooled analysis from Phase 1 and Phase 2 studies, and another demonstrating that quizartinib enhances the activity of chemotherapy in an in vivo preclinical model of AML harboring the FLT3-ITD mutation.  The findings from those presentations are described below.

"AML is amongst the most challenging hematological malignancies to treat, and very few treatment advances have been made in several decades," said Jorge Cortes, M.D., Internist and Professor, Deputy Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, and primary investigator for the Phase 2 Study.  "A significant portion of AML patients have activating FLT3 mutations, and these patients have a particularly poor prognosis and often relapse or are refractory to current treatment options.  These clinical and preclinical results with quizartinib in FLT3-ITD positive AML are encouraging, and support conduct of further studies of this promising compound both as a monotherapy and in combination with other treatments."

A Phase 2 Open-Label, AC220 Monotherapy Efficacy Study in Patients with Refractory/Relapsed FLT3-ITD Positive Acute Myeloid Leukemia:  Updated Interim Results

The updated clinical response and safety data are from a planned interim analysis of a 62 patient subset from the ongoing Phase 2 multi-center study being conducted in the United States and Europe. Pat
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