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Ambit Biosciences Initiates First Phase 2 Clinical Trial of AC220 in Acute Myeloid Leukemia
Date:12/11/2009

SAN DIEGO, Dec. 11 /PRNewswire/ -- Ambit Biosciences Corporation announced today the enrollment and dosing at the University of Texas M. D. Anderson Cancer Center of the first patient in the ACE (AC220 Monotherapy Efficacy) Phase 2 pivotal trial in patients with relapsed or refractory acute myeloid leukemia (AML). AC220 is a novel, orally available, potent and highly selective small molecule that was specifically designed as a FMS-like tyrosine kinase-3 (FLT3) inhibitor. The ACE study is designed to be a pivotal trial that could potentially support a United States regulatory filing for AC220 to address a targeted AML patient population with the internal tandem duplication (ITD) activating mutation for FLT3.

"Based on the promising results of our first-in-human clinical trial presented at the American Society of Hematology (ASH), we are pleased to advance AC220 into this important Phase 2 study in AML. We are deeply grateful to our investigators, their staff, and their patients, as well as our entire team at Ambit, for their vital contributions in achieving this significant milestone," said Wendell Wierenga, EVP of Research and Development at Ambit. "If the ACE study is successful, AC220 could emerge as the first once-a-day, orally available targeted therapy for AML patients. Over the next several months we plan to initiate additional clinical trials with AC220 to support the potential registration in AML, and to explore its utility in certain types of solid tumors."

"AML is a devastating disease for which few treatment options exist," said Jorge Cortes MD, Internist and Professor, Deputy Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, and principal investigator for the ACE Study. "There are no treatments currently approved by the FDA that specifically target the activating ITD mutations of the FLT3 kinase, present in 2
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