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

5 to 40 percent of AML patients, and a key prognostic factor of clinical outcome. Not only has AC220 demonstrated clinical activity in patients with FLT3 ITD mutations, but the drug has also been well tolerated. We look forward to continuing to evaluate the safety and efficacy of AC220 as a single agent in relapsed and refractory AML patients."

Phase 2 ACE Study Design

The ACE study is a single-arm, Phase 2 multinational clinical trial that will evaluate a 200 mg dose of AC220, taken orally once daily as a monotherapy treatment in FLT3 ITD-positive AML patients who have relapsed or are refractory after first-line AML therapy, age 60 years or older, or after second-line AML therapy or stem cell transplant, age 18 years or older. The co-primary endpoints of the study are overall composite complete remission rate and complete remission rate. Secondary endpoints include duration of remission, progression-free survival, overall survival, safety and tolerability. The ACE study is scheduled to enroll 180 patients across an estimated 100 sites in the United States, Canada, France, Germany, Italy, the Netherlands, Poland, Spain, and the United Kingdom. Screening at several sites in the United States has already commenced, and study initiation at additional sites in the United States, Canada and Europe is expected to commence in early 2010.

The study is based on data from a first-in-human Phase 1 clinical trial of AC220 presented earlier this month at the ASH meeting in New Orleans. The preliminary results from that trial in heavily pre-treated AML patients (median of four prior courses of therapy) with predominantly relapsed or refractory AML showed that AC220 was generally well tolerated up to and including once daily continuous dosing of 200 mg, and no treatment-related mortality was observed in the study. Responses were seen in both FLT3 ITD-positive and FLT3 ITD-negative AML patients, with an overall response rate of 56 and 20 pe
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