Date: 2014-09-26
Type of information: Initiation of the trial
phase: 3
Announcement: delay in the initiation of the trial
Company: Pfizer (USA - NY) Glycomimetics (USA - MD)
Product: rivipansel
Action
mechanism: Rivipansel is being developed in partnership with Pfizer to treat vaso-occlusive crisis of sickle cell disease (VOC). The compound is a synthetic glycomimetic molecule, which was rationally designed to inhibit all three selectin types (a pan-selectin inhibitor). 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. Rivipansel may have a number of additional potential applications, including hematologic cancers in which selectins may play a significant role. Selectin-mediated cell adhesion may result in chemotherapy resistance. Selectins have also been shown to facilitate dissemination of cancer cells to bone marrow. Initial evidence from preclinical blood cancer studies shows that rivipansel prevents selectin-mediated cancer cell adhesion and thereby renders cancer cells more sensitive to chemotherapy. Rivipansel has received both Orphan Drug and Fast Track status for VOC from the FDA.
Disease: vaso-occlusive crisis of sickle cell disease (VOC)
Therapeutic area: Hematological diseases - Rare diseases
Country:
Trial details:
Latest
news: * On September 26, 2014, GlycoMimetics announced that it has been informed by Pfizer, the company responsible for ongoing clinical development of rivipansel, that initiation of its Phase 3 clinical trial with rivipansel (GMI-1070) will be significantly delayed due to a manufacturing development issue impacting formulated drug supply. Pfizer advised GlycoMimetics that the issue is under review. Pfizer also noted that upon identifying the specific cause and associated remedy of the manufacturing issue, Pfizer will advise GlycoMimetics of a more specific timeframe regarding the commencement of the Phase 3 study. GlycoMimetics has previously reported that it expected commencement of the trial before the end of 2014. GlycoMimetics entered into an exclusive license agreement with Pfizer for rivipansel in October 2011. The companies are initially developing rivipansel as a potential treatment for vaso-occlusive crisis of sickle cell disease (VOC). Under the license agreement, Pfizer is responsible for the clinical development, regulatory approval and potential commercialization of rivipansel. 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. The company reported topline data from the trial in April 2013 and presented full data from the clinical trial in two oral presentations and one poster presentation at the December 2013 meeting of the American Society of Hematology (ASH.) One of the oral presentations was selected a “Best of ASH.” 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.
