Drugs / T-Guard
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | chronic graft versus host disease | — | “That study was put on hold by the FDA in February 2020” xenikos.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04934670 | Jun → Nov 2022 | acute graft versus host disease | Xenikos | Terminated | No outcome recorded |
| Phase 3 | NCT04128319 | Nov 2019 → Feb 2020 | acute graft versus host disease | Xenikos | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2019-12-03 | Xenikos | Results Xenikos presents promising new data from expanded access program (EAP) using T-Guard® to treat steroid-refractory acute GVHD at ASH Annual Meeting xenikos.com ↗
Consistent with Phase 1/2 testing, T-Guard was well tolerated and significantly improved patient outcome compared to historical controls |
| 2019-10-14 | Xenikos | Regulatory Xenikos receives FDA Fast Track designation for T-Guard® for treating steroid-refractory acute graft-versus-host disease xenikos.com ↗
The Dutch company Xenikos B.V., which develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to T-Guard, Xenikos’ flagship product designed to treat steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients following allogeneic stem cell transplantation. |
| 2019-06-11 | Xenikos | Regulatory Xenikos announces IND clearance by the FDA for a pivotal Phase 3 trial using T-Guard® for treating steroid-refractory acute GVHD xenikos.com ↗
“Receiving FDA approval to initiate our U.S. Phase 3 registration trial is a major milestone for us, as it is the next step in advancing T-Guard towards the market,” says Dr. Ypke van Oosterhout, Chief Executive Officer of Xenikos. |
| 2018-11-16 | Xenikos | Results Final results from T-Guard® Phase 1/2 trial in steroid-resistant aGVHD published in journal BBMT xenikos.com ↗ |
| 2017-12-11 | Xenikos | Results Data from phase 1/2 trial with T‑Guard® presented at ASH Annual Meeting xenikos.com ↗
Twelve of these patients (60%) achieved an overall clinical response (ORR) on day 28, with 10 patients (50%) achieving a complete response (CR). |
| 2016-01-04 | Xenikos | Results Graft versus Host Disease (GVHD) Study Delivers Promising Interim Results xenikos.com ↗
Researchers in the Netherlands and Germany have reported positive interim results of a Phase 1/2 clinical study evaluating T-Guard™ for treatment of steroid-resistant, acute, Graft versus Host Disease (GVHD), a frequent and potentially life-threatening complication of bone marrow and blood stem cell transplantation. |
| 2015-10-01 | Xenikos | Regulatory Clinical Study of T-Guard® in the Treatment of GVHD extends to Germany xenikos.com ↗
Approval from the competent German Authority, the Paul Ehrlich Institute, means that the study can now be extended to Germany, adding the University Hospital Muenster as an additional transplant centre for patients with severe steroid-refractory acute GVHD. |
| 2013-09-18 | Xenikos | Regulatory T-Guard® Receives Orphan Drug Designation for Treatment of GVHD in the US xenikos.com ↗
Xenikos B.V. today announced that T-Guard® has been granted Orphan Drug Designation by the United States (US) Food and Drug Administration (FDA)for the treatment of Graft-versus-Host Disease (GVHD), a frequent and potentially life-threatening complication of bone marrow or blood stem cell transplantation. |
All press releases naming this drug 18 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | T-Guard | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04934670 ↗ |
| Action | Deplete | “leading to depletion of allo-reactive T cells” NCT04128319 ↗ |
| Modality | Protein / enzyme biologic | “Combination Anti-CD3/CD7 Immunotoxin (T-Guard)” NCT04128319 ↗ |
| Route | Intravenous | “administered intravenously” NCT04128319 ↗ |
| Target | CD7 | “Anti-CD3/CD7 immunoconjugate” PMID 37749187 ↗ Sep 2023 |