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

rcent, respectively. Responders in both the FLT3 ITD-positive and FLT3 ITD-negative groups had at least a doubling of median overall survival compared to non-responders (26 vs. nine weeks for FLT3 ITD-positive, and 19 vs. nine weeks for FLT3 ITD-negative. The most common drug-related AEs in the study were gastrointestinal-related (nausea, vomiting, dysgeusia, abdominal pain, anorexia, diarrhea), skin irritation, and peripheral edema. All of these drug-related adverse events occurred in less than 15% of the study population, with most occurring in less than 10% of patients, and were primarily mild to moderate in severity. In addition, some patients experienced QTcF interval prolongation, which was asymptomatic and reversible. The maximum tolerated dose was determined to be 200 mg continuous once-daily dosing.

For more information about the ACE Study, please visit http://www.clinicaltrials.gov/ct2/show/NCT00989261?term=ac220&rank=1, or call 858-334-2136 in the United States, or email to ACEstudy@ambitbio.com.

About AC220

AC220, Ambit's lead product candidate, is a novel, potent, highly selective, orally bioavailable second-generation FLT3 inhibitor currently under evaluation as a monotherapy treatment in adult and elderly patients with relapsed or refractory acute myeloid leukemia (AML). AML is the most common type of blood cancer in adults, and the kinase FLT3 is mutated and constitutively activated in 25-40 percent of such patients. FLT3 ITD mutations predict poor prognosis and decreased response to existing treatments, including chemotherapy and hematopoietic stem cell transplant. Ambit leveraged KINOMEscan(TM), the company's proprietary, high-throughput method for screening small molecule compounds against a large number of human kinases, to advanc
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