GlycoMimetics unveils design of Phase 3 Clinical Trial for GMI-1271 in Relapsed AML

GlycoMimetics unveiled 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. The single pivotal trial is planning to enlist 380 adult patients worldwide and is anticipated to commence in the third quarter of 2018. The primary endpoint will be overall survival, and censoring for transplant in the primary efficacy analysis will not be required. Key secondary endpoints will include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling.

Rachel King, Chief Executive Officer of GlycoMimetics stated “Getting more patients to transplant following treatment with GMI-1271 is one of our goals for this therapy. If we accomplish this, we hope GMI-1271 will contribute to prolonged overall survival for relapsed/refractory AML patients. We believe this is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of this patient population. In addition, we believe that our trial design should streamline the path to data on overall survival, considered the ‘gold standard’ of clinical benefit, and that if this primary endpoint is achieved, it should position GMI-1271 optimally with U.S. and European regulatory agencies, as well as in the marketplace.”

Additional details regarding the Phase 3 trial will be provided in the company’s fourth quarter and fiscal year 2017 financial results teleconference on Tuesday, March 6, 2018, at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 1453008.

GMI-1271 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. In a Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML).