GlycoMimetics, Inc. (GLYC) Announces Agreement With FDA On Special Protocol Assessment For Phase 3 Clinical Trial Of Rivipansel (GMI-1070)
7/1/2014 11:00:36 AM
GAITHERSBURG, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that Pfizer Inc., the company responsible for ongoing clinical development for rivipansel (GMI-1070), has reached agreement with the U.S. Food & Drug Administration (FDA) under a special protocol assessment (SPA) for a Phase 3 trial for rivipansel. A SPA is a written agreement between a trial’s sponsor (in this case, Pfizer) and the FDA regarding the design, endpoints and statistical analysis approach of a Phase 3 clinical trial, results from which could potentially support approval of a New Drug Application (NDA). Rivipansel is being developed as a potential therapy for treatment of patients with sickle cell disease who are hospitalized for vaso-occlusive crisis (VOC).
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