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- | rivipansel (GMI-1070) / GlycoMimetics
Journal: Analogues of the pan-selectin antagonist rivipansel (GMI-1070). (Pubmed Central) - May 26, 2024
The aim of this contribution was to improve the pan-selectin affinity of rivipansel (3) by leveraging a new class of sLex mimetics in combination with an optimized linker length to the sulfate bearing group. As a result, the pan-selectin antagonist 11b exhibits an approximatively 5-fold improved affinity for E-, as well as P-selectin.
- GMI-1687 / GlycoMimetics, uproleselan sodium (APL-106) / GlycoMimetics, rivipansel (GMI-1070) / GlycoMimetics
Glycomimetic drugs targeting E-selectin for inflammatory disease and as a major cause of progression and chemoresistance in cancer (Hybrid; Room 343 (Ernest N. Morial Convention Center)) - Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_2443;
Rivipansel inhibits selectins by mimicking sialyl Lex and the tri-sulfated domain of PSGL-1...GMI-1687 binds E-selectin with a K D of 2.3 nM, is bioavailable through a subcutaneous route, and has recently entered Phase 1 clinical studies...As of August 2023, the reported median survival in this placebo-control blinded study with Uproleselan is over 30 months. Here, data are presented to demonstrate that E-selectin plays a major role in chemoresistance among many cancers and is susceptible to treatment with a potent glycomimetic drug.
- Biologic Assessment of RBC Biology and Neutrophil Activation: Correlation with Sickle Cell Disease Activity (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_1521;
On the other hand, higher HbF levels were associated with lower admission rates for VOE and a trend toward lower levels of neutrophil activation. This suggests that higher HbF, beyond its ability to reduce sickling, also alters other biological characteristics of SS RBCs and is accompanied by reduction in the inflammatory nature of SCD, thereby contributing to a decrease in VOE frequency.
- | rivipansel (GMI-1070) / GlycoMimetics
Journal: Revisiting the structural basis for biological activity of GMI-1070, a sialyl Lewis mimetic. (Pubmed Central) - May 14, 2023
Our results for sialyl Lewis are in agreement with and expand upon prior work. As for the mimetic, our results indicate that, in spite of its conformational restriction, GMI-1070's behavior in solution deviates from what had been proposed, highlighting thus some features that could be optimized, as the development of sialyl Lewis mimetics continues, and new candidates emerge.
- || rivipansel (GMI-1070) / Glycomimetics
Clinical, Journal: A Randomized Clinical Trial of the Efficacy and Safety of Rivipansel for Sickle Cell Vaso-occlusive Crisis (VOC). (Pubmed Central) - Aug 22, 2022
P3
Timing of rivipansel administration after pain onset may be critical to achieving accelerated resolution of acute VOC. Trial Registration: Clinicaltrials.gov, NCT02187003 (RESET), NCT02433158 (OLE).
- || rivipansel (GMI-1070) / Glycomimetics
Clinical, PK/PD data, Journal: Population Pharmacokinetic Analysis of Rivipansel in Healthy Subjects and Subjects with Sickle Cell Disease. (Pubmed Central) - Oct 27, 2021
The pharmacokinetics of rivipansel was well characterized by a two-compartment population pharmacokinetic model. Our results illustrate the important role of simulations in optimizing a potential drug dosing regimen for patients with sickle cell disease and progressive renal impairment.
- || rivipansel (GMI-1070) / Glycomimetics
Clinical, PK/PD data, Journal: Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel. (Pubmed Central) - Sep 29, 2021
P1
The difference observed between rivipansel pharmacokinetics in subjects with moderate hepatic impairment and subjects with normal hepatic function was not considered clinically significant. Single doses of rivipansel were well tolerated in subjects with either renal or hepatic impairment.
- uproleselan sodium (GMI-1271) / Glycomimetics, rivipansel (GMI-1070) / Glycomimetics, GMI-1359 / Glycomimetics
[VIRTUAL] Glycomimetic drugs: From rational design to clinical trials () - Mar 28, 2021 - Abstract #ACSSp2021ACS-Sp_1626;
P3
GMI-1070 (rivipansel) was designed to inhibit E, P, and L-selectins by incorporating a mimic of sialyl Lex together with that of the tri-sulfated domain of PSGL-1...In animal models of VOC, GMI-1687 blocked occlusion and normalized blood flow at 0.04 mg/kg BID...Based on positive phase 2 data, the FDA granted uproleselan “Breakthrough Therapy Designation”...Animal models of bone metastasis treated with GMI-1359 and chemotherapy show reduction of tumor volume and significant improvement in survival. GMI-1359 is now being studied in breast cancer patients at Duke University.
- rivipansel (GMI-1070) / Glycomimetics
[VIRTUAL] Early Initiation of Treatment with Rivipansel for Acute Vaso-Occlusive Crisis in Sickle Cell Disease (SCD) Achieves Earlier Discontinuation of IV Opioids and Shorter Hospital Stay: Reset Clinical Trial Analysis (Channel 20 (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_4468;
P3
These findings suggest the utility of early treatment to shorten or interrupt acute VOCs, analogous to thrombolysis for heart attack or stroke. This could change the VOC treatment paradigm from deferral of hospitalization to one of early intervention to reduce length of hospitalization and IV opioid requirement, relieve VOC symptoms, and possibly mitigate end-organ damage from tissue ischemia.
- GMI-1687 / Glycomimetics, rivipansel (GMI-1070) / Glycomimetics
[VIRTUAL] Restoration of Normal Blood Flow in Mouse Models of Sickle Cell Vaso-Occlusion Following Intravenous or Subcutaneous Administration of a Highly Potent E-Selectin Specific Inhibitor (Channel 20 (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1564;
This could change the VOC treatment paradigm from deferral of hospitalization to one of early intervention to reduce length of hospitalization and IV opioid requirement, relieve VOC symptoms, and possibly mitigate end-organ damage from tissue ischemia. These data demonstrate that the administration of the potent and E-selectin specific compound GMI-1687 was effective in restoring blood flow in two mouse models of SCD, and support the development of GMI-1687 formulated for SC use and self-administration with the potential for early intervention of VOC.
- | rivipansel (GMI-1070) / Glycomimetics
Review, Journal: Lectin antagonists in infection, immunity, and inflammation. (Pubmed Central) - Jul 8, 2020
This evolution has culminated in the transition of the small molecule GMI-1070 into clinical phase III. In this opinion article, an overview of the most important developments of lectin antagonists in the last two decades with a focus on the last five years is given.
- ||||||| rivipansel (GMI-1070) / Glycomimetics
Trial completion date, Trial termination, Trial primary completion date: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Dec 17, 2019
P3, N=153, Terminated, Sponsor: Pfizer
Trial completion date: Jun 2021 --> Nov 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2021 --> Nov 2019; The B5201003 OLE study was terminated based on the failure of the 'parent" B5201002 study to meet its efficacy endpoints. Termination was not due to safety.
- | rivipansel (GMI-1070) / Glycomimetics
Enrollment closed, Enrollment change: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Sep 18, 2019
P3, N=153, Active, not recruiting, Sponsor: Pfizer
Termination was not due to safety. Recruiting --> Active, not recruiting | N=250 --> 153
- ||| rivipansel (GMI-1070) / Pfizer
GlycoMimetics craters as @pfizer says rivipansel flunks phase 3 #sicklecell crisis trial https://t.co/U93T9PUZyU (Twitter) - Aug 5, 2019
- | rivipansel (GMI-1070) / Glycomimetics
Trial completion: RESET: Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Jul 18, 2019
P3, N=341, Completed, Sponsor: Pfizer
Recruiting --> Active, not recruiting | N=250 --> 153 Active, not recruiting --> Completed
- ||||| rivipansel (GMI-1070) / Glycomimetics
Enrollment closed: RESET: Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - May 8, 2019
P3, N=350, Active, not recruiting, Sponsor: Pfizer
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || rivipansel (GMI-1070) / Pfizer
Clinical, P3 data: $GLYC Completes Enrollment in Phase 3 Clinical Trial Evaluating Rivipansel in SCD (Twitter) - May 6, 2019
- |||| rivipansel (GMI-1070) / Glycomimetics
Trial completion date, Trial primary completion date: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Mar 14, 2019
P3, N=250, Recruiting, Sponsor: Pfizer
Recruiting --> Active, not recruiting Trial completion date: Sep 2021 --> Jun 2021 | Trial primary completion date: Sep 2021 --> Jun 2021
- |||| rivipansel (GMI-1070) / Glycomimetics
Trial completion date, Trial primary completion date: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Oct 4, 2018
P3, N=250, Recruiting, Sponsor: Pfizer
Trial completion date: Sep 2021 --> Jun 2021 | Trial primary completion date: Sep 2021 --> Jun 2021 Trial completion date: Jun 2020 --> Aug 2021 | Trial primary completion date: Apr 2019 --> Aug 2021
- |||| rivipansel (GMI-1070) / Glycomimetics
Trial primary completion date: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Sep 6, 2018
P3, N=250, Recruiting, Sponsor: Pfizer
Trial completion date: Jun 2020 --> Aug 2021 | Trial primary completion date: Apr 2019 --> Aug 2021 Trial primary completion date: Oct 2018 --> Apr 2019
- |||| rivipansel (GMI-1070) / Glycomimetics
Trial completion date, Trial primary completion date: RESET: Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Aug 1, 2018
P3, N=350, Recruiting, Sponsor: Pfizer
Trial primary completion date: Oct 2018 --> Apr 2019 Trial completion date: Nov 2018 --> May 2019 | Trial primary completion date: Nov 2018 --> May 2019
- |||| rivipansel (GMI-1070) / Glycomimetics
Trial primary completion date: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Mar 15, 2018
P3, N=250, Recruiting, Sponsor: Pfizer
Trial completion date: Nov 2018 --> May 2019 | Trial primary completion date: Nov 2018 --> May 2019 Trial primary completion date: Jul 2020 --> Oct 2018
- | rivipansel (GMI-1070) / GlycoMimetics
Trial completion, Trial initiation date: A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects (clinicaltrials.gov) - Mar 6, 2018
P1, N=28, Completed, Sponsor: Pfizer
Trial primary completion date: Jul 2020 --> Oct 2018 Recruiting --> Completed | Initiation date: Jun 2016 --> Jun 2016
- rivipansel (GMI-1070) / GlycoMimetics
Trial completion date, Trial initiation date, Trial primary completion date: A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects (clinicaltrials.gov) - Mar 3, 2018
P1, N=28, Recruiting, Sponsor: Pfizer
Recruiting --> Completed | Initiation date: Jun 2016 --> Jun 2016 Trial completion date: Feb 2018 --> Feb 2018 | Initiation date: Jun 2016 --> Jun 2016 | Trial primary completion date: Feb 2018 --> Feb 2018
- ||||| rivipansel (GMI-1070) / Glycomimetics
Trial completion date, Trial initiation date, Trial primary completion date: RESET: Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Feb 26, 2018
P3, N=350, Recruiting, Sponsor: Pfizer
Trial completion date: Feb 2018 --> Feb 2018 | Initiation date: Jun 2016 --> Jun 2016 | Trial primary completion date: Feb 2018 --> Feb 2018 Trial primary completion date: Jul 2018 --> Nov 2018 | Trial completion date: Jul 2018 --> Nov 2018 | Initiation date: Jun 2015 --> Jun 2015
- | rivipansel (GMI-1070) / Glycomimetics
Journal: Selectin catch-bonds mechanotransduce integrin activation and neutrophil arrest on inflamed endothelium under shear flow. (Pubmed Central) - Nov 30, 2017
Neutrophil rolling over E-selectin at precise shear stress transmits tension and catch-bond formation with L-selectin via sLe(x) resulting in focal clusters that deliver a distinct signal to upshift β2-integrins to a high-affinity state. Rivipansel effectively blocked formation of selectin catch-bonds revealing a novel mechanotransduction circuit that rapidly converts extended β2-integrins to high-affinity shear resistant bond clusters with ICAM-1 on inflamed endothelium.
- rivipansel (GMI-1070) / GlycoMimetics
Trial primary completion date: A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects (clinicaltrials.gov) - Sep 1, 2017
P1, N=28, Recruiting, Sponsor: Pfizer
Rivipansel effectively blocked formation of selectin catch-bonds revealing a novel mechanotransduction circuit that rapidly converts extended β2-integrins to high-affinity shear resistant bond clusters with ICAM-1 on inflamed endothelium. Trial primary completion date: Aug 2017 --> Nov 2017
- | rivipansel (GMI-1070) / GlycoMimetics
Trial completion: A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (clinicaltrials.gov) - Apr 19, 2017
P1, N=16, Completed, Sponsor: Pfizer
Trial primary completion date: Aug 2017 --> Nov 2017 Recruiting --> Completed
- | rivipansel (GMI-1070) / Glycomimetics
Trial completion: A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel. (clinicaltrials.gov) - Apr 7, 2017
P1, N=16, Completed, Sponsor: Pfizer
Recruiting --> Completed Recruiting --> Completed
- |||| rivipansel (GMI-1070) / Glycomimetics
Trial primary completion date: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Mar 15, 2017
P3, N=250, Recruiting, Sponsor: Pfizer
Recruiting --> Completed Trial primary completion date: Jan 2020 --> Jul 2020
- rivipansel (GMI-1070) / Glycomimetics
Enrollment open: A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel. (clinicaltrials.gov) - Feb 15, 2017
P1, N=16, Recruiting, Sponsor: Pfizer
Trial primary completion date: Jan 2020 --> Jul 2020 Active, not recruiting --> Recruiting
- rivipansel (GMI-1070) / Glycomimetics
Enrollment closed: A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel. (clinicaltrials.gov) - Feb 1, 2017
P1, N=16, Active, not recruiting, Sponsor: Pfizer
Active, not recruiting --> Recruiting Not yet recruiting --> Active, not recruiting
- | rivipansel (GMI-1070) / Glycomimetics
New P1 trial: A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel. (clinicaltrials.gov) - Dec 20, 2016
P1, N=16, Not yet recruiting, Sponsor: Pfizer
- rivipansel (GMI-1070) / GlycoMimetics
Trial primary completion date: A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (clinicaltrials.gov) - Nov 7, 2016
P1, N=16, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Active, not recruiting Trial primary completion date: Jun 2017 --> Jan 2017
- rivipansel (GMI-1070) / GlycoMimetics
Enrollment open: A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (clinicaltrials.gov) - Oct 16, 2016
P1, N=16, Recruiting, Sponsor: Pfizer
Trial primary completion date: Jun 2017 --> Jan 2017 Not yet recruiting --> Recruiting
- | rivipansel (GMI-1070) / GlycoMimetics
New P1 trial: A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (clinicaltrials.gov) - Aug 19, 2016
P1, N=16, Not yet recruiting, Sponsor: Pfizer
- rivipansel (GMI-1070) / GlycoMimetics
Enrollment open: A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects (clinicaltrials.gov) - Jul 26, 2016
P1, N=28, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | rivipansel (GMI-1070) / GlycoMimetics
New P1 trial: A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects (clinicaltrials.gov) - Jun 27, 2016
P1, N=28, Not yet recruiting, Sponsor: Pfizer
- | rivipansel (GMI-1070) / GlycoMimetics
Trial completion: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects (clinicaltrials.gov) - May 2, 2016
P1, N=27, Completed, Sponsor: Pfizer
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- rivipansel (GMI-1070) / GlycoMimetics
Enrollment closed: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects (clinicaltrials.gov) - Apr 13, 2016
P1, N=27, Active, not recruiting, Sponsor: Pfizer
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- rivipansel (GMI-1070) / GlycoMimetics
Trial initiation date: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects (clinicaltrials.gov) - Nov 14, 2015
P1, N=27, Recruiting, Sponsor: Pfizer
Recruiting --> Active, not recruiting Initiation date: Sep 2014 --> Oct 2015
- rivipansel (GMI-1070) / GlycoMimetics
Enrollment open, Trial primary completion date: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects (clinicaltrials.gov) - Oct 22, 2015
P1, N=27, Recruiting, Sponsor: Pfizer
Initiation date: Sep 2014 --> Oct 2015 Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2015 --> Mar 2016
- ||||| rivipansel (GMI-1070) / Glycomimetics
Trial initiation date: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Oct 6, 2015
P3, N=250, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2015 --> Mar 2016 Initiation date: Jul 2015 --> Oct 2015
- |||||| rivipansel (GMI-1070) / Glycomimetics
Enrollment open: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Sep 24, 2015
P3, N=250, Recruiting, Sponsor: Pfizer
Initiation date: Jul 2015 --> Oct 2015 Not yet recruiting --> Recruiting
- rivipansel (GMI-1070) / GlycoMimetics
Enrollment change: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects (clinicaltrials.gov) - Sep 14, 2015
P1, N=27, Not yet recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting N=15 --> 27
- rivipansel (GMI-1070) / GlycoMimetics
Trial primary completion date: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects (clinicaltrials.gov) - Jul 13, 2015
P1, N=15, Not yet recruiting, Sponsor: Pfizer
N=15 --> 27 Trial primary completion date: Sep 2015 --> Dec 2015
- |||||| rivipansel (GMI-1070) / Glycomimetics
Enrollment open: RESET: Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Jul 8, 2015
P3, N=350, Recruiting, Sponsor: Pfizer
Trial primary completion date: Sep 2015 --> Dec 2015 Not yet recruiting --> Recruiting
- |||||||||| rivipansel (GMI-1070) / Glycomimetics
New P3 trial: Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - May 4, 2015
P3, N=250, Not yet recruiting, Sponsor: Pfizer
- ||||| rivipansel (GMI-1070) / Glycomimetics
Trial initiation date: RESET: Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Apr 15, 2015
P3, N=350, Not yet recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Initiation date: Sep 2014 --> Jun 2015
- ||||| rivipansel (GMI-1070) / Glycomimetics
Trial initiation date: RESET: Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease (clinicaltrials.gov) - Feb 12, 2015
P3, N=350, Not yet recruiting, Sponsor: Pfizer
Initiation date: Sep 2014 --> Jun 2015 Initiation date: Jun 2015 --> Sep 2014