GlycoMimetics Reports Delay In Initiation Of Phase 3 Trial With Rivipansel

(RTTNews) - GlycoMimetics Inc. (GLYC) has been informed by Pfizer (PFE), the company responsible for ongoing clinical development of rivipansel, that beginning of its Phase 3 study with rivipansel (GMI-1070) would be delayed significantly owing to a manufacturing development issue impacting formulated drug supply.

Pfizer advised GlycoMimetics that the issue is under review and Pfizer is working diligently to remedy the situation. Also, Pfizer said that upon identifying the specific cause and associated remedy of the manufacturing issue, Pfizer would advise GlycoMimetics of a more specific timeframe regarding the commencement of the Phase 3 study.

GlycoMimetics has earlier reported that it expected commencement of the trial before the end of 2014. GlycoMimetics signed an exclusive license deal with Pfizer for rivipansel in October 2011. The firms are initially developing rivipansel as a potential treatment for vaso-occlusive crisis of sickle cell disease. According to the license agreement, Pfizer is accountable for the clinical development, regulatory approval and potential commercialization of rivipansel.