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Ambit Announces Presentation of Results from Phase 2 ACE Study of Quizartinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) at the Annual Meeting of the American Society of Clinical Oncology
Date:6/4/2013

CHICAGO, June 4, 2013 /PRNewswire/ -- Ambit Biosciences Corporation (Nasdaq: AMBI) announced today that multiple presentations from the Phase 2 ACE study of quizartinib (AC220), a FLT3 inhibitor, were presented at the Annual Meeting of the American Society of Clinical Oncology.

Data presented included analyses of the 333 patients with relapsed or refractory acute myeloid leukemia (AML) from a Phase 2 clinical trial of quizartinib as monotherapy. In the study, quizartinib was administered orally, once-a-day, in 28-day treatment cycles until disease progression, elective hematopoietic stem cell transplantation (HSCT) or unacceptable toxicity. Based on the positive data from the Phase 2 clinical trial, as well as ongoing discussions with the Food and Drug Administration (FDA), Ambit is planning to initiate a Phase 3 clinical trial in FLT3-ITD positive patients with relapsed or refractory AML in early 2014.

Data Presentations

High Response Rate and Bridging to Hematopoietic Stem Cell Transplantation with Quizartinib (AC220) in Patients with FLT3‑ITD Positive or Negative Relapsed/Refractory AML after Second Line Chemotherapy or Previous Bone Marrow Transplant (Abstract #7012)
Jorge Cortes , M.D., Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

Data from 176 patients, aged 18 years or older, with either relapsed disease or who were refractory to second-line chemotherapy or HSCT were presented. Of the 136 FLT3 positive patients, 35 percent were successfully bridged to a potentially curative HSCT, with the greatest proportion receiving a HSCT after achieving a CRi (complete remission with incomplete hematologic recovery) with quizartinib. Additionally, 33 percent of patients who were bridged to HCST afte
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