CAMBRIDGE, Mass., Sept. 29, 2016 (GLOBE NEWSWIRE) -- Epizyme, Inc. (NASDAQ: EPZM ), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that it has appointed Pamela Strode to the position of vice president of regulatory affairs and quality assurance. Strode will report to Epizyme’s president and chief executive officer, Robert Bazemore and will oversee all of the Company’s activities related to global regulatory strategy, including upcoming interactions with regulatory authorities regarding tazemetostat and global filings.
“This next year will be transformational for Epizyme as we advance the clinical development of tazemetostat and aim to engage with regulators in 2017,” said Bazemore. “Pam’s extensive regulatory and oncology experience will be essential to our success, guiding our path to registration for tazemetostat and driving forward our pipeline in the years ahead.”
Epizyme’s lead product candidate, tazemetostat, is a first-in-class EZH2 inhibitor currently being studied in Phase 2 programs in patients with non-Hodgkin lymphoma (NHL) and in patients with genetically defined solid tumors. The Company plans to present data on tazemetostat’s efficacy and safety from both Phase 2 studies in the first half of 2017. In addition, dependent upon the data, the Company plans to meet with regulatory authorities, beginning with the U.S. Food and Drug Administration (FDA), to review data from its Phase 2 genetically defined solid tumor study and discuss registration strategies in mid-2017. Epizyme also expects to meet with FDA to review Phase 2 NHL data and discuss registration strategies in 2017.
“I’m delighted to be joining the Epizyme team during such an exciting time,” said Strode. “I look forward to applying my experience in oncology and expedited drug development to advance the tazemetostat program and our pipeline, with the goal of bringing new therapies to patients with few or no other treatment options. Our strategic approach to developing tazemetostat may offer multiple accelerated paths forward for the treatment of genetically defined solid tumors and hematological cancers.”
A 35-year healthcare industry veteran, Strode most recently served as vice president, regulatory affairs at Cerulean Pharma, Inc. with a focus on oncology nanoparticle drug conjugate development. Strode previously held progressively senior regulatory positions, supporting global development and U.S. marketed products in oncology, immunology and virology at Boehringer Ingelheim Pharmaceuticals, Inc. (BI), and oncology and infectious disease development products at Bristol-Myers Squibb. She also led the U.S. product labeling development and maintenance function at BI. Strode received a B.S. in microbiology from Cook College at Rutgers University and an M.S. in quality assurance and regulatory affairs from Temple University.
About Epizyme, Inc. Epizyme, Inc. is a clinical-stage biopharmaceutical company creating novel epigenetic therapeutics for cancer patients. Epizyme has built a proprietary product platform that the Company uses to create small molecule inhibitors of chromatin modifying proteins (CMPs), such as histone methyltransferases or HMTs. CMPs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of CMPs, making them oncogenic (cancer-causing). By focusing on the genetic drivers of cancers, Epizyme's targeted science seeks to match the right medicines with the right patients.
For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; whether results from clinical studies will warrant meetings with regulatory authorities or submissions for regulatory approval; expectations for regulatory approvals to conduct trials or to market products; whether the Company’s cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the "Risk Factors" section of the Company's most recent Form 10-Q filed with the SEC and in the Company's other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.
Epizyme Contact: Julie DiCarlo, Epizyme, Inc. jdicarlo@epizyme.com (617) 401-0721
