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GlycoMimetics Appoints Regulatory Veteran Lisa DeLuca as Vice President, Regulatory Affairs
Rhea-AI Impact
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Rhea-AI Sentiment
(Very Positive)
Tags
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Rhea-AI Summary
GlycoMimetics, Inc. (Nasdaq: GLYC) announced the appointment of Lisa DeLuca, Ph.D., as Vice President of Regulatory Affairs. Dr. DeLuca, an experienced regulatory expert, has held significant roles at various firms, including leading global NDA submissions. Her expertise will enhance GlycoMimetics' engagement with the FDA regarding ongoing trials of uproleselan for acute myeloid leukemia (AML). Uproleselan is currently in Phase 3 trials and has received Breakthrough Therapy Designation from the FDA, aimed at improving treatment outcomes in AML patients.
Positive
Expertise of Lisa DeLuca expected to enhance regulatory strategy and agency interactions.
Ongoing trials for uproleselan may benefit from her leadership, especially for FDA submissions.
Uproleselan's Breakthrough Therapy Designation highlights its potential in treating AML.
ROCKVILLE, Md.--(BUSINESS WIRE)--
GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that Lisa DeLuca, Ph.D., has joined its executive leadership team as Vice President, Regulatory Affairs. Dr. DeLuca is a veteran regulatory expert who has previously led the strategy-formation and execution of multiple global NDA submissions and product registrations. Most recently she was the head of regulatory affairs at Nuvation Bio and a member of its executive leadership team.
“Lisa is a seasoned executive who brings to GlycoMimetics significant expertise in regulatory strategy and agency interactions. She has successfully led programs requiring interface with both the FDA and international authorities. Most notably, while at Celator Pharmaceuticals, she directed regulatory activities surrounding the submission of an NDA for Vyxeos, which led to its approval for the treatment of newly diagnosed acute myeloid leukemia patients. Her decision to join GlycoMimetics as head of our regulatory affairs group represents an important step forward as we prepare to engage more definitively with the FDA with respect to the potential successful outcomes of the two ongoing registrational trials of uproleselan in AML. Her expertise in oncology and hematology constitutes a unique fit with both our late-stage uproleselan program and the Company’s pipeline opportunities," commented Harout Semerjian, GlycoMimetics’ Chief Executive Officer.
Dr. DeLuca’s regulatory experience spans the drug development spectrum from pre-IND to post-approval and life cycle management. She is passionate about bringing safer, more effective oncology drugs to cancer patients, and she has spent the majority of her regulatory career in the oncology therapeutic area. She holds undergraduate and master’s degrees in biology from Eastern Michigan University, earned her Ph.D. from the University of Toledo, and was a postdoctoral fellow at the University of Michigan.
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.
Forward-Looking Statements
This press release contains forward-looking statements regarding the planned clinical development and potential regulatory interactions for the Company’s drug candidates. 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 March 2, 2021, 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.
What is the significance of Lisa DeLuca's appointment at GlycoMimetics?
Lisa DeLuca's appointment as Vice President of Regulatory Affairs is significant as she brings extensive experience in regulatory strategy that can enhance GlycoMimetics' interactions with the FDA for its drug candidates.
How might Lisa DeLuca's expertise impact the ongoing trials of uproleselan?
Her regulatory expertise is expected to positively influence the management and potential success of the ongoing Phase 3 trials of uproleselan for AML, improving the chances for successful FDA submissions.
What is uproleselan and its current status in clinical trials?
Uproleselan is an investigational drug by GlycoMimetics, currently in Phase 3 trials for acute myeloid leukemia (AML), and has received Breakthrough Therapy Designation from the FDA.
What previous experience does Lisa DeLuca have that is relevant to her new role?
Lisa DeLuca has previously led global NDA submissions and has held regulatory leadership positions at Nuvation Bio and Celator Pharmaceuticals, significantly impacting drug approvals.
