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Epizyme's EPZ-5676 DOT1L Inhibitor Demonstrates Encouraging Initial Findings in an Ongoing Phase 1 Dose Escalation Study
Date:11/14/2013

CAMBRIDGE, Mass., Nov. 14, 2013 /PRNewswire/ --

  • Four dose cohorts (12, 24, 36 and 54 mg/m2/day) completed (16 patients, 8 with acute leukemia with MLL-r) with 21-day on/7-day off administration schedule
  • Observations to date include:
    • No dose-limiting toxicities; maximum tolerated dose (MTD) not reached
    • Treatment effects, consistent with genetically defined therapeutic mechanism of action, observed in 4 of 8 acute leukemia patients with MLL-rearrangement (MLL-r); no effects observed in non-MLL-r patients
    • Dose-proportional exposure
    • Dose- and time-dependent methyl mark inhibition
  • Plan to initiate Phase 1 MLL-r only expansion stage in December 2013 starting at an 80 mg/m2/day uninterrupted treatment schedule, continued dose escalation possible
  • Epizyme will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss these data; slides will be available on www.epizyme.com prior to call

Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced initial findings from an ongoing Phase 1 study of EPZ-5676, a potent and selective inhibitor of the DOT1L histone methyltransferase (HMT) being developed for the treatment of acute leukemia with alterations in the MLL gene.

"EPZ-5676 is a first-in-class inhibitor of the DOT1L HMT, and we are very pleased with the findings to date in the dose escalation stage of the ongoing two-stage Phase 1 study," said Robert J. Gould, Ph.D., chief executive officer, Epizyme. "The safety,
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