GlycoMimetics Says Pfizer Plans To Initiate Phase 3 Trial With Rivipansel

(RTTNews) - GlycoMimetics, Inc. (GLYC) said Pfizer (PFE) has informed the company that it anticipates initiating a planned Phase 3 clinical trial with rivipansel (GMI-1070) in mid-2015.

GycoMimetics said that Pfizer has advised the company that the clinical supply issue which has delayed the start of this trial has been discussed with the FDA. Based on these discussions, Pfizer anticipates the study being able to start enrollment in mid-2015, following FDA review of amended study documents.

As per terms of the license agreement between the two companies, Pfizer is scheduled to make a $20 million milestone payment to GlycoMimetics once the first patient is dosed in the Phase 3 clinical trial. This milestone is the second of two scheduled milestone payments totaling $35 million upon initiation of the Phase 3 clinical trial. Pfizer previously paid GlycoMimetics $15 million in May 2014.

The company stated that Rivipansel is initially being developed as a potential treatment for vaso-occlusive crisis or VOC of sickle cell disease. Under the license agreement, Pfizer is responsible for the clinical development and regulatory submission and, if approved, the commercialization of rivipansel.

Rivipansel has received both Orphan Drug and Fast Track status for the treatment of VOC from the FDA, and Orphan Product status in the European Union, the company noted.