Patients are at the center of everything we do at GlycoMimetics and we are deeply grateful to the people living with life-threatening diseases who consent to participate in clinical research to advance our understanding of potential medicines in development. Through collaboration with our clinical partners, our goal is to develop medicines that extend and improve the lives of patients. We do this through the conduct of high-quality clinical research designed to provide regulatory authorities with the robust data required for review and approval.
- Uproleselan (GMI-1271): In November 2021, the company-sponsored pivotal Phase 3 trial (NCT03616470) in patients with relapsed/refractory acute myeloid leukemia who are considered to be medically eligible to receive intensive chemotherapy completed enrollment. In the fall of 2022 the US Food and Drug Administration cleared the addition of an interim analysis, as blinded pooled survival data showed patients living longer than expected based on the historical benchmarks used to design the study. The interim analysis was reviewed by the study’s Independent Data Monitoring Committee (IDMC) in February 2023. Following review, the IDMC recommended the study continue to the originally planned final overall survival events trigger, currently expected within the first half of 2024. The IDMC expressed no concerns about patient safety in connection with its review of the study data.
- Uproleselan (GMI-1271) is being evaluated by the National Cancer Institute as a potential new treatment for newly diagnosed AML patients fit for chemotherapy (NCT04964505). Enrollment in the Phase 2 portion of the Phase 2/3 study has been completed and suspended until the results of Phase 2 are announced by NCI.
Other Clinical Programs:
- To learn more about other clinical trials involving our product candidates, please visit ClinicalTrials.gov: a publicly and privately supported registry of clinical studies involving human participants conducted around the world. To find information on trials run by GlycoMimetics, our development partners, or by independent investigators, use the “Search for Studies” function and enter the product candidate’s name (e.g., uproleselan).