Drugs / Allocetra-OTS
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06208241 | Jul 2023 → Sep 2026 overdue | osteoarthritis, knee | Amir Oron | Active not recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT04513470 | Aug 2020 → Jan 2021 | COVID-19 | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 1 | NCT03925857 | Jan → Dec 2019 | infectious disease with sepsis | Enlivex Therapeutics Ltd. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05581719 | Nov 2022 → Apr 2024 | peritoneal carcinomatosis | Enlivex Therapeutics RDO Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05431907 | Jun 2022 → Mar 2024 | peritoneal carcinomatosis | Enlivex Therapeutics RDO Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 23 trials | ||||||
| Phase 2 | NCT04922957 | Sep 2021 → Apr 2022 | COVID-19 | Enlivex Therapeutics Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04612413 | Nov 2020 → Jan 2024 | acute cholecystitis, infectious disease with sepsis, pneumonia, urinary tract infection | Enlivex Therapeutics Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04590053 | Oct 2020 → Feb 2021 | COVID-19 | Hadassah Medical Organization | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04659304 Comparator | Dec 2021 → Sep 2022 | COVID-19 | Enlivex Therapeutics Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2022-09-12 | Enlivex Therapeutics Ltd. | Results Enlivex Announces New Preclinical Data in Murine Mesothelioma Model Showing a Substantial Survival Benefit with Allocetra as Monotherapy and in Combination with Cisplatin at the ESMO Congress 2022 enlivex.com ↗
Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced new preclinical data in a murine mesothelioma model showing a substantial and statistically significant survival benefit when Allocetra™ is combined with the chemotherapeutic agent, cisplatin. |
| 2022-05-31 | Enlivex Therapeutics Ltd. | Results Enlivex Announces New Preclinical Data in Ovarian Cancer Showing a Substantial Survival Benefit when Allocetra is Combined with PD-1 Checkpoint Inhibition at the American Society of Clinical Oncology (ASCO) Annual Meeting enlivex.com ↗
The study showed substantial and statistically significant improvements in survival benefit, survival duration and tumor burden reduction when Allocetra™ was combined with an anti-PD1 checkpoint inhibitor. |
| 2022-05-09 | Enlivex Therapeutics Ltd. | Results Enlivex Presented Substantial Survival Benefit of Allocetra in Combination with Immune Checkpoint Inhibitor in Mesothelioma Cancer Study at the International Society for Cell and Gene Therapy Annual 2022 Meeting enlivex.com ↗
Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, announced the poster presentation of a substantial survival benefit of AllocetraTM combined with immune checkpoint inhibition in a preclinical mesothelioma study at the International Society of Cell and Gene Therapy Annual 2022 Meeting. |
| 2020-03-18 | Enlivex Therapeutics Ltd. | Results Enlivex Announces Positive Final Safety and Efficacy Data From Clinical Trial of Off-The-Shelf Allocetra in Patients with Severe Sepsis enlivex.com ↗
Final Analysis Comparing 10 AllocetraTM-Treated Patients with 37 Matched Controls Showed Significant Positive Responses in State of Organ Failure, ICU Hospitalization and Mortality in a Highly Fragile and Extremely Difficult to Treat Population with Severe Sepsis |
| 2020-02-20 | Enlivex Therapeutics Ltd. | Results Data On Enlivex’s Allocetra-OTS Immunotherapy for Peritoneal Solid Tumors and for Prevention of GvHD Selected for Presentation at the Transplantation & Cellular Therapy Meetings Conference (TCT) in Orlando, Florida enlivex.com ↗
Results from preclinical and clinical studiesy suggested that a single infusion of donor early apoptotic cells (Allocetra) as prophylaxis for GvHD in myeloablative HSCT is safe and potentially effective and led to 0% (0/6) of acute high grade II-IV GvHD |
| 2019-11-04 | Enlivex Therapeutics Ltd. | Results Enlivex Therapeutics Announces Positive Interim Safety and Efficacy Data From Ongoing Trial of Off-The-Shelf Allocetra in Patients with Severe Sepsis enlivex.com ↗
Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced positive interim efficacy data from the Company’s ongoing Phase Ib clinical trial in patients with severe sepsis. |
| 2019-10-10 | Enlivex Therapeutics Ltd. | Results Preclinical Data Indicating Allocetra-OTS As Potential Therapy For Prevention Of Organ Failure And Mortality Associated with Severe Sepsis Selected For Presentation At The XVIIIth Congress Of the European and Int’l Shock Societies enlivex.com ↗
The data showed ten-fold (10x) increased survival for study subjects who were treated with Allocetra-OTS therapy and antibiotics and fluids, as compared to subjects treated solely with antibiotics and fluids. |
| 2019-10-07 | Enlivex Therapeutics Ltd. | Results Data On Combination Of Allocetra-OTS Immunotherapy and CAR-T Therapy Designed For Treating Solid Tumors Selected For Presentation At The European Molecular Biology Organization’s 2019 Cell Death in Immunity and Inflammation Workshop enlivex.com ↗
Enlivex’s data showed significantly increased duration of survival and overall survival for study subjects who were treated with the combination therapy, as compared to stand-alone solid tumor CAR-T therapy. |
| 2019-09-23 | Enlivex Therapeutics Ltd. | Results First Data On Combination Of Enlivex’s Allocetra-OTS Immunotherapy and CAR-T Therapy Designed For Treating Solid Tumors Revealed At The Joint IIS-ISCR Special 2019 Conference enlivex.com ↗
The results of these preclinical studies showed that the mechanism of action significantly increased the anti-tumor macrophage population surrounding the human solid tumor microenvironment in the subjects who were treated with the combination therapy. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Allocetra-OTS | “The primary aim of this phase IB study was to determine the safety profile of Allocetra™-OTS (early apoptotic cell) infusion in subjects presenting to the emergency room with sepsis.” PMID 34659208 ↗ Sep 202110“apoptotic cells (Allocetra™-OTS, Enlivex Therapeutics), a cellular immunomodulatory therapy that reprograms macrophages to reduce hyper-inflammatory response severity.” PMID 37600829 ↗ Aug 2023 |
| Modality | Cell therapy | “The study drug, Allocetra-OTS is a cell-based therapeutic composed of donor apoptotic cells.” NCT03925857 ↗ |
| Route | Intravenous | “Subjects will receive single intravenous (IV) administration of investigational product” NCT04513470 ↗ |