GlycoMimetics Announces Continuation of Phase 3 Study of E-selectin Antagonist Uproleselan in Relapsed/Refractory AML to Originally Planned Final Analysis Following Interim Analysis by Independent Data Monitoring Committee
February 15, 2023 at 08:00 am EST
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GlycoMimetics, Inc. announced the independent Data Monitoring Committee (DMC) reviewed the interim utility analysis of its Phase 3 study of uproleselan in relapsed/refractory (R/R) acute myeloid leukemia (AML) and recommended the study should continue to the originally planned final overall survival event trigger. The interim utility analysis was added to the study in the fall of 2022 as blinded pooled survival data showed patients living longer than expected based on the historical benchmarks used to design the study. The plan for the independent DMC to review efficacy and safety data at approximately 80% of planned survival events was cleared with the U.S. Food and Drug Administration.
GlycoMimetics, Inc. is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML) and for inflammatory diseases. It is developing a pipeline of glycomimetics, which are small molecules that mimic the structure of carbohydrates involved in biological processes, to inhibit disease-related functions of carbohydrates, such as the roles they play in inflammation, cancer and infection. Its drug candidates include Uproleselan, GMI-1687, Galectin Antagonists and GMI-1359. It is developing Uproleselan, a specific E-selectin antagonist, to be used in combination with chemotherapy to treat patients with AML, a life-threatening hematologic cancer, and potentially other hematologic cancers. It has designed an antagonist of E-selectin, GMI-1687, that is suitable for subcutaneous administration. GMI-1359 is a drug candidate that simultaneously targets both E-selectin and a chemokine receptor (CXCR4).
GlycoMimetics Announces Continuation of Phase 3 Study of E-selectin Antagonist Uproleselan in Relapsed/Refractory AML to Originally Planned Final Analysis Following Interim Analysis by Independent Data Monitoring Committee