GlycoMimetics Reports Delay in Initiation of Phase 3 Trial with Rivipansel

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GlycoMimetics, Inc.
GLYC
announced today that it has been informed by Pfizer
PFE
, the company responsible for ongoing clinical development of rivipansel, that initiation of its Phase 3 clinical trial with rivipansel (GMI-1070) will be significantly delayed due 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. Pfizer also noted that upon identifying the specific cause and associated remedy of the manufacturing issue, Pfizer will advise GlycoMimetics of a more specific timeframe regarding the commencement of the Phase 3 study. GlycoMimetics has previously reported that it expected commencement of the trial before the end of 2014. GlycoMimetics entered into an exclusive license agreement with Pfizer for rivipansel in October 2011. The companies are initially developing rivipansel as a potential treatment for vaso-occlusive crisis of sickle cell disease (VOC). Under the license agreement, Pfizer is responsible for the clinical development, regulatory approval and potential commercialization of rivipansel.
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