Trusted Resources: Evidence & Education
Scientific literature and patient education texts
Randomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use
authors: Telen MJ, Wun T, McCavit TL, De Castro LM, Krishnamurti L, Lanzkron S, Hsu LL, Smith WR, Rhee S, Magnani JL, Thackray Hsummary/abstract:
Treatment of vaso-occlusive crises (VOC) or events in sickle cell disease (SCD) remains limited to symptom relief with opioids. Animal models support the effectiveness of the pan-selectin inhibitor GMI-1070 in reducing selectin-mediated cell adhesion and abrogating VOC. We studied GMI-1070 in a prospective multicenter, randomized, placebo-controlled, double-blind, phase 2 study of 76 SCD patients with VOC. Study drug (GMI-1070 or placebo) was given every 12 hours for up to 15 doses. Other treatment was per institutional standard of care. All subjects reached the composite primary end point of resolution of VOC. Although time to reach the composite primary end point was not statistically different between the groups, clinically meaningful reductions in mean and median times to VOC resolution of 41 and 63 hours (28% and 48%, P = .19 for both) were observed in the active treatment group vs the placebo group. As a secondary end point, GMI-1070 appeared safe in acute vaso-occlusion, and adverse events were not different in the two arms. Also in secondary analyses, mean cumulative IV opioid analgesic use was reduced by 83% with GMI-1070 vs placebo (P = .010). These results support a phase 3 study of GMI-1070 (now rivipansel) for SCD VOC. This trial was registered at www.clinicaltrials.gov as #NCT01119833.organization: Duke University, Durham, NC; University of California Davis Medical Center and VA Northern California Health Care System, Sacramento, CA; University of Texas Southwestern Medical Center, Dallas, TX; University of Pittsburgh, Pittsburgh, PA; Emory University School of Medicine, Atlanta, GA; Johns Hopkins School of Medicine, Baltimore, MD; University of Illinois, Chicago, IL; Virginia Commonwealth University, Richmond, VA; Rho, Inc., Chapel Hill, NC; GlycoMimetics, Inc., Gaithersburg, MD
read more full text
Children and adolescents with sickle cell disease have worse cold and mechanical hypersensitivity during acute painf...Sickle cell disease (SCD) pain associate...
Feasibility of an internet-enabled tablet-based guided imagery for stress and pain reduction intervention in adults ...Pain of sickle cell disease (SCD) has bo...
Multidisciplinary Care Team Greatly Reduces Risk in Pregnant SCD Patients in Low-income CountriesAccording to a study published in the Am...
FDA Approves Novel Treatment to Target Abnormality in Sickle Cell DiseaseToday, the U.S. Food and Drug Administra...
bluebird bio Announces Publication of Case Study on First Patient with Severe Sickle Cell Disease Treated with Gene ...Patient treated with LentiGlobinTM drug ...
Researchers ID key drivers of heart complications in sickle cell anemiaStudy opens path to earlier diagnosis, t...
Alzheimer’s Treatment Memantine Shows Promise in Treating Sickle Cell DiseaseMemantine, a standard treatment for Alzh...
The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.