GlycoMimetics Announces Agreement with FDA on Special Protocol Assessment for Phase 3 Clinical Trial of Rivipansel (GMI-1070)
- Rivipansel is in clinical development as a potential therapy for treatment of vaso-occlusive crisis in patients with sickle cell disease -
Rivipansel has previously received both Orphan Drug and Fast Track
status for the treatment of VOC from the
"There is an enormous need in the sickle cell community for new
therapies to treat this debilitating disease," said
About Sickle Cell Disease
There are more than 80,000 people in the U.S. with sickle cell disease, and many of them have multiple, acute VOCs annually. These painful crises result in more than 75,000 hospitalizations per year in the U.S., with an average stay of approximately six days.
About Rivipansel
The compound is a synthetic glycomimetic molecule, which was rationally
designed to inhibit all three selectin types (a pan-selectin inhibitor).
Selectins are glycoprotein cell adhesion molecules implicated in
inflammatory processes. To achieve adequate therapeutic activity in
certain inflammatory disorders, inhibition of all three selectin types
(E-selectin, L-selectin and P-selectin) may be required.
In the Phase 2 trial, patients treated with rivipansel experienced
reductions in time to reach resolution of VOC, length of hospital stay
and use of opioid analgesics for pain management, in each case as
compared to patients receiving placebo.
About
This press release contains forward-looking statements regarding
GlycoMimetics' planned activities with respect to the clinical
development of GMI-1070 and other matters. Actual results may differ
materially from those in these forward-looking statements. For a further
description of the risks associated with these statements, as well as
other risks facing
bhahn@glycomimetics.com
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