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Epizyme, Inc. Provides Third Quarter 2013 Financial Results and Corporate Update
Date:10/22/2013

n 2014: Based on the findings to date in the Phase 1 study of EPZ-5676 in adults, Epizyme plans to initiate a Phase 1 trial of EPZ-5676 in pediatric patients with MLL-r leukemia in the first half of 2014. The study will initially be open in approximately 5-6 investigational sites in the U.S.
  • Broadening Program into AML with MLL-PTD in 2014: Epizyme plans to initiate a clinical study of EPZ-5676 in patients with AML with a genetic alteration called MLL-PTD. MLL-PTD cell lines and animal models exhibit similar sensitivity to DOT1L inhibition as seen in MLL-r pre-clinical studies. This data was presented on October 21, 2013, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. MLL-PTD accounts for an estimated 5-7% of adult AML cases with an estimated annual incidence of 2,300 patients in the major markets (U.S., EU and Japan) and represents a meaningful potential expansion of the clinical opportunity for EPZ-5676.
  • EPZ-6438 Clinical Development – Progress and Plans

  • Initiated Dose Escalation Study: In June 2013 Epizyme announced the enrollment of the first patient in a Phase 1/2 study of EPZ-6438 (referred to as E7438 by Eisai). The Phase 1 dose escalation study is ongoing at two sites in France, and no dose-limiting toxicities have been observed to date. The companies also plan to significantly increase the number of clinical sites in 2014, and to submit an IND in the U.S., in anticipation of the Phase 2 initiation.  
  • Phase 2 Initiation Expected in 2014: With partner Eisai, Epizyme plans to initiate the Phase 2 portion of this study in 2014 after completion of the dose escalation phase. This phase will only enroll patients with non-Hodgkin lymphoma with oncogenic point mutations in EZH2 and is expected to provide an initial assessment of therapeutic effect
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