Randomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use.

Blood
Marilyn J TelenHelen Thackray

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 ...Continue Reading

References

Nov 22, 2001·JAMA : the Journal of the American Medical Association·E P OrringerJ M Grindel
Feb 15, 2002·Current Opinion in Hematology·Paul S Frenette
Mar 7, 2002·Proceedings of the National Academy of Sciences of the United States of America·Aslihan TurhanPaul S Frenette
Apr 4, 2003·JAMA : the Journal of the American Medical Association·Martin H SteinbergMichael Terrin
Aug 5, 2004·The Journal of Biological Chemistry·Julia E BrittainLeslie V Parise
Apr 26, 2005·American Journal of Hematology·Samir K Ballas, Margaret Lusardi
Apr 10, 2009·American Journal of Hematology·Teresa L KaufAbraham G Hartzema
Apr 2, 2010·American Journal of Preventive Medicine·Kathryn L Hassell
Apr 8, 2010·JAMA : the Journal of the American Medical Association·David C BrousseauClaudia A Steiner
Mar 3, 2011·JAMA : the Journal of the American Medical Association·Mark T GladwinUNKNOWN DeNOVO Investigators
Apr 3, 2012·British Journal of Haematology·Lori StylesUNKNOWN Sickle Cell Disease Clinical Research Network (SCDCRN)

❮ Previous
Next ❯

Citations

Jul 15, 2015·Current Opinion in Structural Biology·Kurt Drickamer, Maureen E Taylor
Nov 26, 2015·Blood Cells, Molecules & Diseases·Venina Marcela DominicalNicola Conran
Apr 12, 2016·Translational Research : the Journal of Laboratory and Clinical Medicine·Yunus AlapanUmut A Gurkan
Feb 3, 2016·Chest·Enrico M Novelli, Mark T Gladwin
Oct 6, 2015·Trends in Pharmacological Sciences·Takashi AngataMatthew S Macauley
Jul 17, 2015·American Journal of Hematology·Natasha ArcherCarlo Brugnara
Jul 1, 2015·British Journal of Haematology·Kenneth I Ataga, Jonathan Stocker
Apr 16, 2016·Pediatric Blood & Cancer·Mark NimmerUNKNOWN sickle cell working group of the Pediatric Emergency Care Applied Research Network (PECARN)
May 23, 2015·Cardiovascular Research·Rodger P McEver
Apr 8, 2016·Current Opinion in Hematology·Gregory J Kato
Aug 24, 2016·British Journal of Haematology·Marilyn J TelenMaria Lindgren
Oct 6, 2016·Pediatric Research·Emily Riehm Meier, Angeli Rampersad
Oct 28, 2016·Expert Review of Medical Devices·Yunus AlapanUmut A Gurkan
Apr 8, 2017·Blood·William A Eaton, H Franklin Bunn
Oct 17, 2017·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Wally R SmithJohn Roberts
Feb 11, 2016·World Journal of Clinical Pediatrics·Lorenzo IughettiDonatella Venturelli
Nov 9, 2017·CPT: Pharmacometrics & Systems Pharmacology·Brinda K Tammara, Lutz O Harnisch
May 17, 2017·Journal of Clinical Pharmacology·Brinda K TammaraJoan M Korth-Bradley
Sep 30, 2017·Angewandte Chemie·Stefanie WagnerAlexander Titz
Apr 12, 2018·Annual Review of Genomics and Human Genetics·Thomas N Williams, Swee Lay Thein
Dec 1, 2018·Expert Opinion on Pharmacotherapy·Lidiane Torres, Nicola Conran
Jan 19, 2019·The FEBS Journal·Maureen E Taylor, Kurt Drickamer
Mar 21, 2019·Current Opinion in Hematology·Anupam AichKalpna Gupta
Sep 13, 2018·Blood·Swee Lay Thein, Jo Howard
Aug 1, 2019·Expert Review of Hematology·Carlton Dampier
Oct 5, 2017·Pharmaceuticals·Shifaza Mohamed, Deirdre R Coombe
Dec 29, 2018·American Journal of Respiratory and Critical Care Medicine·Prithu Sundd, Wolfgang M Kuebler
Oct 17, 2019·Clinical Pharmacology and Therapeutics·Julie Kanter, Sophie Lanzkron
Jun 27, 2017·Current Opinion in Hematology·Jing Li, Jaehyung Cho
Mar 7, 2020·British Journal of Haematology·Amina Nardo-MarinoDavid Rees
Mar 14, 2020·Current Opinion in Hematology·Lei YuJames D Engel

❮ Previous
Next ❯

Related Concepts

Related Feeds

Anemia

Anemia develops when your blood lacks enough healthy red blood cells. Anemia of inflammation (AI, also called anemia of chronic disease) is a common, typically normocytic, normochromic anemia that is caused by an underlying inflammatory disease. Here is the latest research on anemia.

Adhesion Molecules in Health and Disease

Cell adhesion molecules are a subset of cell adhesion proteins located on the cell surface involved in binding with other cells or with the extracellular matrix in the process called cell adhesion. In essence, cell adhesion molecules help cells stick to each other and to their surroundings. Cell adhesion is a crucial component in maintaining tissue structure and function. Discover the latest research on adhesion molecule and their role in health and disease here.

Blood And Marrow Transplantation

The use of hematopoietic stem cell transplantation or blood and marrow transplantation (bmt) is on the increase worldwide. BMT is used to replace damaged or destroyed bone marrow with healthy bone marrow stem cells. Here is the latest research on bone and marrow transplantation.

© 2022 Meta ULC. All rights reserved