Drugs / RGI-7000
RGI-7000
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00003985 | Sep 1998 → ? | lung cancer | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00352235 | Aug 2003 → May 2005 | chronic hepatitis C virus infection | Foundation for Liver Research | Completed | No outcome recorded |
| Phase 1/2 | NCT00363155 | Mar 2003 → Jul 2006 | chronic hepatitis B virus infection | Foundation for Liver Research | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2024-04-15 | Regimmune Corporation | Results REGiMMUNE Announces the Poster Presentation at the AACR 2024 Annual Meeting for RGI-2001 Phase 2b latest analyses. regimmune.com ↗
The results from exploratory correlative analyses are consistent with the proposed mechanism of action of RGI-2001. |
| 2024-03-01 | Regimmune Corporation | Results Tandem 2024: REGiMMUNE’s RGI-2001 Demonstrates Higher acute GFS without Increased Relapse from the Phase 2b Study regimmune.com ↗
Through day 100, the incidence of grades II-IV aGVHD was 22.9% of subjects on RGI-2001 compared to 38.8% of those in the CIBMTR cohort. |
| 2023-12-27 | Regimmune Corporation | Results REGiMMUNE to Present Results from the Phase 2b Study of RGI-2001 at the 2024 Tandem Meeting regimmune.com ↗
Based on the analysis, RGI-2001 showed reduced incidence of aGVHD with an excellent safety profile. |
| 2022-12-19 | Regimmune Corporation | Results REGiMMUNE Presented Positive Results of RGI-2001 in the Reduction of Acute GvHD from Phase 2b Study at the 2022 ASH annual meeting regimmune.com ↗
RGI-2001 was well tolerated and associated with a meaningful reduction in the incidence of severe acute GVHD |
| 2022-11-07 | Regimmune Corporation | Results REGiMMUNE to Present Results from the Phase 2b Study of RGI-2001 at the 2022 ASH Annual Meeting regimmune.com ↗
Based on the analysis, RGI-2001 showed reduced incidence of aGVHD with an excellent safety profile. |
| 2021-02-04 | Regimmune Corporation | Results REGiMMUNE presented at the ASH annual meeting on 5 December 2020 regimmune.com ↗
Plasma levels of KRN7000 were similar in each patient after the first dose and multiple doses. |
| 2014-02-28 | Regimmune Corporation | Results American Journal of Transplantation Reports REGiMMUNE’s Preclinical Results of its Method for Long-term Tolerance in Organ Transplantation regimmune.com ↗
Mechanistic studies of this combination treatment revealed a synergistic expansion of tolerogenic dendritic cells (plasmacytoid dendritic cells) that results in the downstream increase of regulatory T cells. |
| 2012-11-14 | Regimmune Corporation | Regulatory RGI-2001 was granted Orphan Drug Designation from FDA regimmune.com ↗
REGiMMUNE Corporation announced today that RGI-2001, the company’s liposomal formulation of alpha-GalCer, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of Graft-versus-Host Disease (GvHD) associated with hematopoietic stem cell transplantation. |
| 2012-11-14 | Regimmune Corporation | Regulatory RGI-2001 was granted Orphan Drug Designation from FDA regimmune.com ↗
REGiMMUNE Corporation announced today that RGI-2001, the company’s liposomal formulation of alpha-GalCer, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of Graft-versus-Host Disease (GvHD) associated with hematopoietic stem cell transplantation. |
| 2010-11-22 | Regimmune Corporation | Results Publication of GvHD paper regimmune.com ↗
Importantly, this study demonstrated for the first time that a compound, RGI-2001, expands naturally occurring regulatory T (nTreg) cells to extend survival of animals in in vivo GvHD model. |
| 2009-05-12 | Regimmune Corporation | Results REGiMMUNE Presented Enhanced Efficacy Data in Preclinical Transplantation Models at the 2009 American Transplant Congress regimmune.com ↗
REGiMMUNE Corporation today announced that its lead product candidate RGI-2001, in combination with a low-dose of Sirolimus, demonstrated enhanced efficacy in transplantation tolerance induction in models of skin transplantation and acute Graft-versus-Host disease (GvHD). |
| 2008-11-06 | Regimmune Corporation | Results REGiMMUNE to Present at the 50th ASH Annual Meeting regimmune.com ↗
A Liposomal Formulation of KRN7000 (RGI-2001) Potently Reduces GvHD Lethality through the Expansion of CD4+Foxp3+ Regulatory T cells in Murine Models. |
All press releases naming this drug 12 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RGI-7000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL384200 ↗ |
| Known as | (2S, 3S, 4R)-1-O-(a-D-galactopyranosyl)-N-hexacosanoyl-2-amino-1,3,4-octadecanetriol | “Patients with chronic hepatitis C who met the inclusion criteria are assigned to receive a-GalCer (KRN7000 ((2S, 3S,...” NCT00352235 ↗ |
| Known as | .alpha.-galcer | ChEMBL registry synonym — accepted as the source's own label CHEMBL384200 ↗ |
| Known as | a-GalCer | “Patients with chronic hepatitis C who met the inclusion criteria are assigned to receive a-GalCer (KRN7000 ((2S, 3S,...” NCT00352235 ↗ |
| Known as | AGL-582 | ChEMBL registry synonym — accepted as the source's own label CHEMBL384200 ↗ |
| Known as | Alpha-galactosylceramide | ChEMBL registry synonym — accepted as the source's own label CHEMBL384200 ↗ |
| Known as | KRN7000 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00003985 ↗ |
| Action | Inhibit | “KRN7000 is reported to inhibit HBV replication in HBV transgenic mice.” NCT00363155 ↗ |
| Modality | Small molecule | — CHEMBL384200 ↗ |
| Route | Intravenous | “by slow intravenous injection” NCT00003985 ↗ |