On November 15, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported completion of enrollment of its pivotal Phase 3 trial evaluating uproleselan in addition to a standard chemotherapy regimen in patients with relapsed/refractory AML (Press release, GlycoMimetics, NOV 15, 2021, View Source [SID1234595613]). A total of 388 patients across 70 sites in nine countries has now been randomized in the clinical trial, which has a primary endpoint of overall survival, not censored for transplant. GlycoMimetics reiterates its guidance that, based upon current projections, it expects topline results after year-end 2022.
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"We believe that uproleselan is clearly a novel and potent inhibitor of E-selectin. Should the ongoing registrational trial prove positive, we will have created a foundational paradigm shift that has the potential to significantly impact outcomes for our patients with relapsed or refractory AML," commented Daniel J. DeAngelo, M.D., 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 microenvironment-extrinsic pathways in AML will be essential for the successful clinical translation of new, more effective drug combination strategies. As a potential first-in-class therapeutic that selectively disrupts extrinsic pathways of chemoresistance, we believe uproleselan can be transformative for AML patients," commented Harout Semerjian, GlycoMimetics’ Chief Executive Officer.
"Given the worldwide logistical challenges of the ongoing global pandemic, I want to thank our investigators and their staff, in addition to our clinical team and CRO partners, for their dedication and resilience in getting 388 patients enrolled. We are optimistic that the Phase 3 data from this trial will confirm the findings of our Phase 1/2 trial: specifically, a high rate of complete responses, measurable residual disease negativity, successful transplant and extended survival, "Mr. Semerjian continued.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an 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. FDA and from the Chinese National Medical Products Administration 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.