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news.Pfizer has started patient enrollment in the Phase III clinical trial (RESET) evaluating the efficacy and safety of rivipansel, an investigational pan-selectin inhibitor, to treat vaso-occlusive crisis in hospitalized individuals with sickle cell disease (SCD) who are six years of age or older.
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Selectins are a family of molecules, which are believed to play a major role in regulating cellular interactions within blood vessels.
SCD is a rare and debilitating chronic disease, and is one of the most prevalent genetic disorders in the US.
The multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III trial is planning to enroll at least 350 people with sickle cell disease and will evaluate the efficacy and safety of treatment with rivipansel.
The company said that participants in the trial must be receiving treatment with intravenous opioids for their vaso-occlusive crisis and must be able to receive the first dose of study drug within 24 hours of initiation of intravenous opioid therapy.
Sickle Cell Disease Association of America president and chief operating officer Sonja Banks said: "Scientific innovation cannot forge ahead without the patients that are willing to work with the scientific community by participating in clinical trials.
"Patients should speak with their healthcare providers if they are interested in learning more about how to participate in a trial."
The primary endpoint of the trial will be time to readiness-for- discharge and key secondary endpoints will include time to discharge, cumulative IV opioid consumption and time to discontinuation of IV opioids.
Pfizer Rare Diseases, Global Innovative Pharmaceuticals Business medicine team lead and vice president Brenda Cooperstone said: "We are pleased to enroll the first patient in the Reset trial, which will further our understanding of the potential role of rivipansel for the treatment of painful crises in patients with sickle cell disease."
In 2011, Pfizer and GlycoMimetics entered into a worldwide license agreement for the development and, if approved by applicable regulatory authorities, commercialization of rivipansel.
GlycoMimetics was responsible for development up to Phase II and Pfizer will be responsible for all future clinical development of rivipansel.
The initiation of the Phase III trial triggered the second of two milestone payments from Pfizer to GlycoMimetics totaling $35m.
Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.