Pfizer Inc. PFE announced the enrolment of the first patient in the phase III RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study on its pan-selectin inhibitor, rivipansel (GMI-1070). Rivipansel is being developed for the treatment of patients (six years of age or older) suffering from sickle cell disease who are hospitalized for vaso-occlusive crisis.
The multicenter, randomized, double-blind, placebo-controlled, parallel-group study is being conducted to evaluate the efficacy and safety of rivipansel. The primary endpoint of the study, which will enroll at least 350 patients, will be time to readiness-for-discharge.
We remind investors that Pfizer had entered into a worldwide licensing agreement with GlycoMimetics GLYC for rivipansel in Oct 2011. GlycoMimetics was responsible for the development of the candidate up to phase II, while Pfizer will handle further development and commercialization of the candidate.
The initiation of the phase III study has triggered a $20 million milestone payment to GlycoMimetics, adding to a $15 million payment received in May 2014. GlycoMimetics’ shares jumped 12.1% on the news.
According to the press release issued by Pfizer, sickle cell disease, one of the most prevalent genetic disorders in the U.S., is estimated to affect more than 100,000 people – causing more than 75,000 hospitalizations every year.
We note that rivipansel enjoys both Fast Track as well as orphan drug status in the U.S. Moreover, the study is being conducted under the FDA’s special protocol assessment program.
Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Hospira Inc. HSP. Both hold a Zacks Rank #1 (Strong Buy).
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