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

his Phase 1 dose escalation study is ongoing and no dose-limiting toxicities have been observed to date."

"Looking ahead to 2014, we plan to pursue additional clinical studies for both candidates in genetically defined cancers beyond the primary indications, including MLL-PTD for EPZ-5676 and synovial sarcoma and other INI1-deficient tumors for EPZ-6438," said Gould. "We are in a strong position to invest in Epizyme's internally generated pipeline and look forward to continued progress with multiple proof of concept studies in 2014."

EPZ-5676 Clinical Development – Progress and Plans

  • Top-line Dose Escalation Data Expected in Fourth Quarter of 2013: The dose escalation stage of the ongoing Phase 1 study of EPZ-5676 is nearing completion, and Epizyme plans to disclose top-line dose escalation data in the fourth quarter of 2013.
  • Clinical Sites Added: Five clinical sites have been added this year, bringing the total number of clinical sites participating in this study to six.
  • Granted Orphan Drug Designation: EPZ-5676 was granted orphan drug designation by the U.S. FDA in August 2013.
  • MLL-r Restricted Expansion Cohort Stage to Begin in Fourth Quarter of 2013: Based on data from the dose escalation stage, Epizyme plans to initiate the expansion cohort stage of the ongoing Phase 1 study in the fourth quarter of 2013. The expansion cohort will be limited to patients with MLL-r and is expected to provide an initial assessment of therapeutic effect in MLL-r patients in 2014. It will include as many as 12 sites in both the United States and Europe. Abbott Molecular Inc., under its collaboration with Epizyme, is developing a molecular companion diagnostic to identify eligible MLL-r patients for EPZ-5676, and the Investigational Use Only (IUO) diagnostic will be available for use in the expansion cohort.
  • Initiation of Pediatric MLL-r Phase 1 Study i
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