Pfizer has enrolled the first patient in its Phase III clinical trial (Reset) of rivipansel, an investigational pan-selectin inhibitor, to treat vaso-occlusive crisis (VOC) in patients hospitalised with sickle cell disease (SCD) who are six years of age or older.
Around 350 people with sickle cell disease will be enrolled in the Rivipansel: Evaluating Safety, Efficacy and Time to Discharge (Reset) trial, which will evaluate the efficacy and safety of rivipansel.
The company said that patients in the trial must be receiving treatment with intravenous opioids for their VOC and must be able to receive the first dose of study drug within 24 hours of initiation of intravenous opioid therapy.
The trial’s primary endpoint will be time to readiness-for- discharge, while key secondary endpoints will include time to discharge, cumulative IV opioid consumption and time to discontinuation of IV opioids.
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."
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SCD, a rare and debilitating chronic disease, is one of the most prevalent genetic disorders in the US and life expectancy for females and males with this disease is 48 and 42 years, respectively.
Pfizer Rare Diseases, Global Innovative Pharmaceuticals Business medicine team lead and vice-president Brenda Cooperstone said: "We are pleased to enrol 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."
Pfizer and GlycoMimetics had entered into a worldwide license agreement in 2011 to develop and, if approved by applicable regulatory authorities, commercialise rivipansel.
GlycoMimetics was responsible for development of the product up to Phase II, while Pfizer will carry out all future clinical development of rivipansel.
The start of this Phase III trial triggered the second of two milestone payments from Pfizer to GlycoMimetics totalling $35m.
Earlier, rivipansel has received both orphan drug and fast track status to treat VOC from the FDA, and an orphan product status in the European Union (EU).
The company is conducting the Phase III trial under a Special Protocol Assessment (SPA), in agreement with the FDA.
Image: Normal blood cells next to a sickle-blood cell, coloured scanning electron microscope image. Photo: courtesy of OpenStax College.