Date: 2014-07-01
Type of information: Initiation of development program
phase: 3
Announcement: agreement under a special protocol assessment
Company: Pfizer (USA - NY) GlycoMimetics (USA - MA)
Product: rivipansel
Action
mechanism: Rivipansel is a synthetic glycomimetic molecule, which was rationally designed to inhibit all three selectin types. Selectins are glycoprotein cell adhesion molecules implicated in inflammatory processes. To achieve adequate therapeutic activity in certain inflammatory disorders, inhibition of all three selectin types (E-selectin, L-selectin and P-selectin) may be required. GlycoMimetics has conducted a Phase 2 randomized, double-blinded study examining the efficacy, safety and pharmacokinetics of rivipansel in hospitalized sickle cell disease patients experiencing VOC. GlycoMimetics enrolled 76 patients ages 12 to 60 at 22 trial sites in the United States and Canada. In the Phase 2 trial, patients treated with rivipansel experienced reductions in time to reach resolution of VOC, length of hospital stay and use of opioid analgesics for pain management, in each case as compared to patients receiving placebo. GlycoMimetics was responsible for this phase 2 study and Pfizer will be responsible for any future clinical development of rivipansel.
Disease: treatment of patients with sickle cell disease who are hospitalized for vaso-occlusive crisis (VOC)
Therapeutic area: Hematologic diseases - Genetic diseases - Rare diseases
Country: USA
Trial details:
Latest
news: * On July 1, 2014, GlycoMimetics announced that Pfizer, the company responsible for ongoing clinical development for rivipansel (GMI-1070), has reached agreement with the FDA under a special protocol assessment (SPA) for a Phase 3 trial for rivipansel. A SPA is a written agreement between a trial’s sponsor (in this case, Pfizer) and the FDA regarding the design, endpoints and statistical analysis approach of a Phase 3 clinical trial, results from which could potentially support approval of a New Drug Application (NDA). Rivipansel is being developed as a potential therapy for treatment of patients with sickle cell disease who are hospitalized for vaso-occlusive crisis (VOC). This pan-selectin inhibitor) has previously received both Orphan Drug and Fast Track status for the treatment of VOC from the FDA. Pfizer plans to begin the Phase 3 program before the end of 2014.
