ROCKVILLE, Maryland, November 15, 2021– (BUSINESS WIRE) – GlycoMimetics, Inc. (Nasdaq: GLYC) today announced the completion of the recruitment of its pivotal Phase 3 trial evaluating uproleselan in addition to a standard chemotherapy regimen in patients with relapsed / refractory AML. A total of 388 patients at 70 sites in nine countries have now been randomized to the clinical trial, which has overall survival, uncensored for transplantation, as primary endpoint. GlycoMimetics reiterates its forecast that, based on current projections, it expects superior results after the end of 2022.
“We believe that uproleselan is clearly a potent new inhibitor of E-selectin. If the current registration trial proves positive, we will have created a fundamental paradigm shift that has the potential to have a significant impact. on the outcomes of our patients with relapsed or refractory AML, “commented Daniel J. DeAngelo, MD, Ph.D., Dana Farber Cancer Institute in Boston, who is the principal investigator of this multinational phase 3 trial.
“Our belief is that drug combinations targeting both tumor intrinsic and microenvironmental extrinsic pathways in AML will be critical for the successful clinical translation of new, more effective drug combination strategies. drug resistance, we believe that uproleselan can transform AML patients, ”commented Harout Semerjian, CEO of GlycoMimetics.
“Given the global logistical challenges of the ongoing global pandemic, I would like to thank our researchers and their staff, in addition to our clinical team and CRO partners, for their dedication and resilience in enrolling 388 patients. We are optimistic that the phase 3 data from this trial will confirm the results of our phase 1/2 trial: in particular, a high rate of complete responses, measurable residual negativity of the disease, successful transplantation and prolonged survival, “Mr. Semerjian continued.
Discovered and developed by GlycoMimetics, uproleselan is a targeted E-selectin inhibitor, the first in its class. Uproleselan (yoo ‘pro le’ sel an), currently in a full phase 3 development program in AML, has received breakthrough therapy designation from the US FDA and the Chinese National Medical Products Administration for the treatment of adult patients with relapsed or refractory AML disease. Uproleselan is designed to prevent E-selectin (an adhesion molecule on bone marrow cells) from binding to cancer cells in the blood as a targeted approach to disrupt the well-established resistance mechanisms of leukemia cells in the bone marrow microenvironment.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company that discovers and develops glycobiology-based therapies for cancers, including acute myeloid leukemia and inflammatory diseases with high unmet need. The Company’s science is based on understanding the role carbohydrates play on the surface of every living cell and on applying its specialized chemistry platform to discover small molecule drugs, called glycomimetics, that modify these mediated pathways. by carbohydrates in various disease states. , including signaling in cancer and inflammation. As a leader in this field, GlycoMimetics leverages this unique targeted approach to advance its portfolio of wholly-owned drug candidates, with the goal of developing transformative therapies for serious illnesses. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.
This press release contains forward-looking statements. These forward-looking statements include those relating to the expected or potential clinical development of the Company’s product candidate, uproleselan, as well as the Company’s expectations regarding the presentation of clinical trial data, and the potential benefits and impact of the uproleselan. Actual results may differ materially from those described in these forward-looking statements. For a more detailed description of the risks associated with these statements, as well as other risks that GlycoMimetics faces, please see the risk factors described in the Company’s annual report on Form 10-K filed with the Securities and Exchange Commission. (SEC) of the United States on March 2. , 2021, and other filings that GlycoMimetics makes from time to time with the SEC. Forward-looking statements speak only as of the date of this release, and GlycoMimetics assumes no obligation to update or revise such statements, except as required by law.
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