Drugs / LIS1
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06495723 | Jul 2024 → Jul 2026 overdue | peripheral T-cell lymphoma, not otherwise specified | Xenothera SAS | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04431219 | Nov 2019 → Mar 2022 | — | Xenothera SAS | Completed | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2024-02-28 | Xenothera SAS | Results XENOTHERA : publication of the first-in-human trial of LIS1 in Solid Organ Transplantation xenothera.com ↗
Results confirming the safety and efficacy of the product were recently published in Transplantation, the reference peer-reviewed journal of the domain. |
| 2023-09-12 | Xenothera SAS | Regulatory [Press Release] New hope for patients: XENOTHERA granted orphan drug designation (ODD ) from the FDA for LIS1 in the treatment of T-lymphomas. xenothera.com ↗
L ’agence américaine du médicament (FDA), au vu des données scientifiques et médicales de XENOTHERA, vient de conférer au LIS1 la désignation de médicament orphelin (ODD) dans l’indication Lymphomes T. |
| 2022-07-18 | Xenothera SAS | Regulatory [Press Information] Orphan designation by the European Medicines Agency for LIS1, the transplant induction therapy from XENOTHERA xenothera.com ↗
Le Comité des Médicaments Orphelins - Committee for Orphan Medicinal Products (COMP) - a rendu publi que le 27 juin son opinion positive pour la désignation orpheline du LIS1 dans le traitement de la transplantation d’organe solide. |
| 2022-06-10 | Xenothera SAS | Results [Press Information] XENOTHERA presents LIS1 results at the American Transplant Congress (ATC) in Boston xenothera.com ↗
At the American Transplant Congress, Professor Ondrej Viklicky from the IKEM Institute - one of Europe's leading kidney transplant centers for several decades (Prague, Czech Republic) - principal investigator of the NCT04431219 trial, presented the first results of the LIS1 Phase I/II First In Human (FIH) clinical trial, which ran from September 5, 2019 to March 28, 2022 (last patient visit). |
| 2022-06-10 | Xenothera SAS | Results [Press Alert] Safety and efficacy results of LIS1 xenothera.com ↗
Le critère principal de jugement était la sécurité du produit, LIS1 a été bien toléré. |
| 2019-09-13 | Xenothera SAS | Regulatory XENOTHERA receives approval for first in man Kidney Transplant Clinical Trial xenothera.com ↗
XENOTHERA announces it has received Czech Republic regulatory agency approval to begin its Phase I/II clinical trial of its LIS1 product developed as induction treatment in solid organ transplantation. |
| 2019-09-13 | Xenothera SAS | Results XENOTHERA presents at ESOT 2019 xenothera.com ↗
It demonstrates the interest of LIS1 vs other products in its depletion scheme (quality and duration of the lymphocyte depletion). |
| 2019-07-30 | Xenothera SAS | Regulatory XENOTHERA announces receivability of its Clinical Trial Application at the Czech Republic regulatory agency for a first in man clinical trial of LIS1 in kidney transplanted patients with dose escalation. xenothera.com ↗
XENOTHERA announces receivability after its submission of a Clinical Trial Application (CTA) with Czech Republic regulatory agency for a Phase I/II trial of its LIS1 product developed as induction treatment in solid organ transplantation. |
| 2019-03-01 | Xenothera SAS | Results Xenothera Announces Publication in European Journal of Clinical Investigation on Immunological Mechanisms Underlining Use of LIS1 xenothera.com ↗
Xenothera announced publication in European Journal of Clinical Investigation of data detailing the expected benefit of LIS1 for kidney graft recipients. |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LIS1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06495723 ↗ |
| Action | Deplete | “caused time-limited T cell depletion” PMID 38421879 ↗ Feb 2024 |
| Modality | Protein / enzyme biologic | “a stabilized solution of purified anti-T lymphocytes polyclonal glyco-humanized swine IgG” NCT04431219 ↗ |
| Route | Intravenous | “Multiple Ascending Intravenous Doses of LIS1” NCT04431219 ↗ |