Pfizer initiates rivipansel in Phase III RESET trial for vaso-occlusive crisis of Sickle Cell Disease

Pfizer Inc.has announced that the first patient has been enrolled in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study � a Phase III clinical trial assessing the efficacy and safety of rivipansel (GMI 1070) for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease who are six years of age or older.

This phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study is planning to enroll at least 350 people with sickle cell disease, aged six and older who are hospitalized for a vaso-occlusive crisis and will evaluate the efficacy and safety of treatment with rivipansel. Study participants 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. The primary endpoint for the study will be time to readiness-for- discharge. Key secondary endpoints will include time to discharge, cumulative IV opioid consumption and time to discontinuation of IV opioids.

Comment: A Phase II study of GMI 1070 was led by GlycoMimetics,the originator of the drug, in patients experiencing vaso-occlusive crisis (VOC) of sickle cell disease. This randomized, double-blind, placebo-controlled trial examined the efficacy, safety and pharmacokinetics of GMI-1070, in hospitalized patients with sickle cell disease experiencing VOC. Patients treated with GMI 1070 experienced reduction in duration of vaso-occlusive crisis, reduction in length of hospital stay, and reduction in the use of narcotic pain relief. Both adult and paediatric patients demonstrated improvement, and adverse event rates were comparable between GMI-1070 and placebo.

Comment: Pfizer has licensed world wide rights to GMI 1070 from GlycoMimetics.