2015
Randomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use
Telen M, Wun T, McCavit T, De Castro L, Krishnamurti L, Lanzkron S, Hsu L, Smith W, Rhee S, Magnani J, Thackray H. Randomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use. Blood 2015, 125: 2656-2664. PMID: 25733584, PMCID: PMC4408290, DOI: 10.1182/blood-2014-06-583351.Peer-Reviewed Original ResearchConceptsVaso-occlusive crisisSickle cell diseaseComposite primary end pointPrimary end pointPhase 2 studyEnd pointRandomized phase 2 studySCD vaso-occlusive crisisOpioid analgesic useSecondary end pointsActive treatment groupPhase 3 studyVaso-occlusive eventsAnalgesic usePlacebo groupProspective multicenterStudy drugAdverse eventsOpioid useSymptom reliefMedian timeSCD patientsCell diseaseTreatment groupsAnimal models
2014
A Multi-Center Randomized Controlled Trial of Intravenous Magnesium for Sickle Cell Pain Crisis in Children
Brousseau D, Scott J, Badaki O, Darbari D, Chumpitazi C, Airewele G, Ellison A, Smith-Whitley K, Mahajan P, Sarnaik S, Casper T, Cook L, Dean M, Leonard J, Hulbert M, Powell E, Liem R, Hickey R, Krishnamurti L, Hillery C, Panepinto J. A Multi-Center Randomized Controlled Trial of Intravenous Magnesium for Sickle Cell Pain Crisis in Children. Blood 2014, 124: 88. DOI: 10.1182/blood.v124.21.88.88.Peer-Reviewed Original ResearchSickle cell pain crisisLength of stayAcute chest syndromePediatric Emergency Care Applied Research NetworkQuality of lifePain crisisPediatric emergency medicine physiciansOpioid useIntravenous magnesiumSickle cell diseaseEmergency medicine physiciansMorphine equivalentsPlacebo groupStudy drugAdverse eventsDrug infusionCell diseaseMedicine physiciansHistory of ACSMAGIC studyMulti-Center Randomized Controlled TrialSickle cell vasoocclusive crisisAcute intervention trialDecreased opioid useFirst drug infusionPan-Selectin Antagonist Rivipansel (GMI-1070) Reduces Soluble E-Selectin Levels While Improving Clinical Outcomes in SCD Vaso-Occlusive Crisis
Wun T, Telen M, Krishnamurti L, McCavit T, DeCastro L, Flanner H, Kuypers F, Larkin S, Rhee S, Magnani J, Thackray H. Pan-Selectin Antagonist Rivipansel (GMI-1070) Reduces Soluble E-Selectin Levels While Improving Clinical Outcomes in SCD Vaso-Occlusive Crisis. Blood 2014, 124: 2704. DOI: 10.1182/blood.v124.21.2704.2704.Peer-Reviewed Original ResearchSoluble E-selectin levelsPhase 2 trialVaso-occlusive crisisSE-selE-selectin levelsClinical outcomesAdhesion molecule-1Placebo groupLast doseSubgroup analysisE-selectinMolecule-1Sickle cell disease vaso-occlusive crisisDouble-blind phase 2 trialSoluble adhesion molecules E-selectinBaseline white blood cell countRandomized phase 2 studySCD vaso-occlusive crisisSoluble adhesion molecule concentrationsAge groupsVascular cell adhesion molecule-1White blood cell countIntercellular adhesion molecule-1Adhesion molecules E-selectinCell adhesion molecule-1
2013
GMI 1070: Reduction In Time To Resolution Of Vaso-Occlusive Crisis and Decreased Opioid Use In a Prospective, Randomized, Multi-Center Double Blind, Adaptive Phase 2 Study In Sickle Cell Disease
Telen M, Wun T, McCavit T, De Castro L, Krishnamurti L, Lanzkron S, Hsu L, Smith W, Rhee S, Magnani J, Thackray H. GMI 1070: Reduction In Time To Resolution Of Vaso-Occlusive Crisis and Decreased Opioid Use In a Prospective, Randomized, Multi-Center Double Blind, Adaptive Phase 2 Study In Sickle Cell Disease. Blood 2013, 122: 776. DOI: 10.1182/blood.v122.21.776.776.Peer-Reviewed Original ResearchVaso-occlusive crisisSickle cell diseaseOpioid useMedian timeTreatment groupsPlacebo groupCell diseaseSustained reductionVisual analog scale pain scoreTotal adverse event rateCumulative opioid useOral pain medicationPatients ages 12Opioid analgesic usePrimary efficacy endpointScale pain scoresPhase 2 studyPhase 3 studyPrimary efficacy analysisAdverse event ratesDaily opioid useStatistical significanceOral analgesiaSerious AEsVAS reduction