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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