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GlycoMimetics (GLYC) Announces Design of Phase 3 Clinical Trial for GMI-1271 in R/R AML

March 5, 2018 4:03 PM EST

GlycoMimetics, Inc. (NASDAQ: GLYC) announced today its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC (Mitoxantrone, etoposide and Ara-C) or in combination with FAI (fludarabine, cytosine arabinoside and idarubicin) in individuals with relapsed/refractory acute myeloid leukemia (AML). The design is aligned with guidance received from the U.S. Food and Drug Administration (FDA). The single pivotal trial is planned to enroll 380 adult patients worldwide and is expected to begin in the third quarter of 2018. The primary endpoint will be overall survival, and censoring for... More