On December 6, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC), a clinical-stage biotechnology company, reported that the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and the Alliance for Clinical Trials in Oncology, have completed enrollment of 267 patients in the Phase 2 portion of the adaptive Phase 2/3 trial evaluating whether uproleselan improves overall survival in newly diagnosed patients 60 years or older with acute myeloid leukemia (AML) (Press release, GlycoMimetics, DEC 6, 2021, View Source [SID1234596480]). The randomized, controlled trial is evaluating the addition of uproleselan, GlycoMimetics’ investigational, first-in-class, targeted antagonist of E-selectin, to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. Completion of enrollment now sets the stage for a planned evaluation of the Phase 2 portion of the trial to determine whether the prespecified threshold for continuing to Phase 3 has been met based on event-free survival (EFS). Geoffrey Uy, M.D., Professor of Medicine, Washington University School of Medicine in St. Louis, is the trial’s Principal Investigator. GlycoMimetics and NCI are collaborating on the development of uproleselan under a Cooperative Research and Development Agreement.
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This press release features multimedia. View the full release here: View Source
"I would like to thank the Alliance for completing the enrollment of the Phase 2 portion despite all of the logistical challenges associated with the pandemic. If the EFS analysis meets the preplanned metric, the data will be transferred confidentially to GlycoMimetics to support regulatory filings for uproleselan in AML, and enrollment will continue in the Phase 3 portion of the trial," said Harout Semerjian, GlycoMimetics Chief Executive Officer. "Together, the GlycoMimetics- and NCI-sponsored programs will constitute a large dataset of 650 patients with AML. We would anticipate filing with regulatory agencies for approval for treatment of patients in both the frontline and relapsed/refractory AML settings should both trials achieve positive readouts."
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist 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 and the Chinese Health authority for the treatment of adult patients with AML who have 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.