ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that veteran regulatory expert Myra Rosario Herrle, PhD, RPh, RAC, has joined the executive management team as Vice President, Regulatory Affairs.
“We look forward to leveraging Myra’s extensive regulatory expertise as we continue to progress our pipeline of novel, small-molecule glycomimetic therapeutics,” said Chief Executive Officer Rachel King. “Her guidance will be particularly welcome as we continue our ongoing Phase 3 registration trial of uproleselan in relapsed or refractory acute myeloid leukemia (AML), and work in collaboration with the National Cancer Institute (NCI) on the institute’s multi-center Phase 3 trial to evaluate the drug candidate in newly-diagnosed patients fit for chemotherapy.”
Dr. Herrle brings 25 years of pharmaceutical industry experience – with 15 years of regulatory experience and a deep background in oncology — to her role at GlycoMimetics. Most recently, she served as Senior Director, Oncology Global Regulatory Strategy at AbbVie. Previously, she held positions of increasing responsibility at Novartis Pharmaceuticals Corporation, including Associate Director of Oncology Regulatory Affairs, Global Program Regulatory Director and Global Therapeutic Area Lead (Executive Director). Prior to Novartis, she was the Therapeutic Area Lead/Director of Oncology at Glaxo Wellcome/GlaxoSmithKline, focusing on oncology, musculoskeletal and inflammatory diseases.
About Uproleselan (GMI-1271)
Discovered and developed by GlycoMimetics, uproleselan is investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics’ wholly-owned drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is being evaluated across a range of patient populations including a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has also completed a Phase 1 clinical trial with another wholly-owned drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.
This press release contains forward-looking statements regarding the clinical development and potential benefits and impact of the Company’s drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company’s wholly-owned product candidates and the receipt of data from Pfizer’s Phase 3 clinical trial of rivipansel. Actual results may differ materially from those in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2020, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.