Allocetra (HLA-matched donor mononuclear enriched leukocytes) / Enlivex Therap - LARVOL DELTA

Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Amir Oron | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Dec 2025 | Trial primary completion date: Jan 2024 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

ENX-CL-05-001: Study of Intra-articular Allocetra in Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=160 | Active, not recruiting | Sponsor: Enlivex Therapeutics Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Enlivex Therapeutics to Showcase Allocetra’s Potential in Osteoarthritis at OARSI 2025 World Congress (GlobeNewswire) - "Enlivex Therapeutics Ltd...today announced that it will present two poster abstracts at the Osteoarthritis Research Society International (OARSI) 2025 World Congress on Osteoarthritis, taking place April 24-27, 2025, in Incheon (Seoul), South Korea....The presentations will feature data from both preclinical and clinical studies evaluating Allocetra...in patients with osteoarthritis."

Clinical data • Preclinical • Osteoarthritis

Enlivex Announces Completion of Enrollment In The Phase II stage Of Its Phase I/II Trial Evaluating Allocetra In Patients With Moderate To Severe Knee Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...today announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and treated in the Phase II stage....The Company expects a topline data readout from the Phase II stage, including full 3-month endpoints, by August 2025."

P2 data • Trial status • Osteoarthritis

SYNERGISTIC IMPACT OF APOPTOTIC CELLS AND CAR T CELL TREATMENTS ON PERITONEAL SOLID TUMORS (EBMT 2025) - "SCID-Bg mice were intraperitoneally (IP) injected with either human HeLa-CD19 or HeLa-CD19-luciferase cells, along with 10×10^6 allocetra-ots or a vehicle control, and 10×10^6 CD19-CAR T cells or mock T cells.Tumors were analyzed for bacterial presence using immunohistochemistry staining with antilipoteichoic acid (LTA) and antilipopolysaccharide (LPS) antibodies... These findings highlight the potential of combining apoptotic cell-based therapy, targeting resident macrophages, with CAR T cell therapy to enhance anti-tumor efficacy."

CAR T-Cell Therapy • IO biomarker • Oncology • Solid Tumor

Enlivex Announces the Dosing of the First Patient in a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...today announced that the first patient has been dosed in an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis."

Trial status • Osteoarthritis

Phase I/II Trial of AllocetraTM Cell Therapy for Knee Osteoarthritis: Clinical Evidence of Response to Modulation of Inflammation (EULAR 2025) - No abstract available

Clinical • P1/2 data • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology

Enlivex Receives Notice of Allowance for Chinese Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...announced that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for patent application number 2020800620493. Once issued, the resulting patent will provide Enlivex with added intellectual property protection in China through at least 2040 with claims covering methods of using Allocetra to treat subjects with osteoarthritis. The Company expects that this new patent will be issued in China during the first half of 2025."

Patent • Osteoarthritis

Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra Trial in Knee Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics...is pleased to invite investors to a live investor webinar on March 5, 2025, at 11:00 a.m. ET to discuss the positive interim six-month data from the Phase I stage of its ongoing randomized, multi-country Phase I/II Allocetra trial in patients with moderate to severe knee osteoarthritis. The exclusive event, hosted by RedChip Companies, will feature the Company’s Chief Executive Officer, Oren Hershkovitz Ph.D., who will provide a detailed review of the interim results..."

P1 data • Osteoarthritis

Enlivex Announces Positive Interim Data – Statistically Significant 47.0% Durable and Persistent Pain Reduction At Six Months, in Patients with Moderate to Severe Knee Osteoarthritis (GlobeNewswire) - P1 | N=160 | NCT06233474 | Sponsor: Enlivex Therapeutics Ltd. | "Statistically significant 47.0% average reduction of reported pain (P=0.0001) compared to average pain level at baseline; 46% improvement in joint function and 40% improvement in joint stiffness; 83% of the patients were still considered as responders to treatment4 after 6 months; No serious adverse events; Efficacy continues to display strong persistence and durability over time, maintaining the 3-month positive effect...This second stage is progressing along the previously announced timeline, and the Company currently expects a topline data readout from the Phase I/II trial by the third quarter of 2025."

P1 data • P1/2 data • Osteoarthritis

Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ) (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Dr. Amit Druyan

New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology

ENX-CL-06-001: Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Enlivex Therapeutics Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis (GlobeNewswire) - "Enlivex Therapeutics...announced the completion of the dosing and initial follow-up period for the first patient in its Phase I clinical trial evaluating the safety, tolerability and potential therapeutic effect of Allocetra following injection into an affected joint in patients with psoriatic arthritis. No safety concerns were recorded following the dosing of the first patient. The trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for psoriatic arthritis."

Trial status • Psoriatic Arthritis

Enlivex Receives Notice of Allowance for Japanese Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...announced that the Japanese Patent Office issued a notice of allowance for patent application number 2022-512861 titled 'THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS'. Once issued, the resulting patent will provide Enlivex with added intellectual property (IP) protection through at least 2040. The Company expects that this new patent will be formally issued in Japan by the end of the second quarter of 2025."

Patent • Osteoarthritis

Enlivex Receives Authorization from the Danish Medicines Agency to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics...announced that the Danish Medicines Agency authorized the initiation of the Phase II stage of the Company’s multi-country Phase I/II trial in moderate and severe knee osteoarthritis. This approval follows the recently announced recommendation by the independent Data and Safety Monitoring Board (DSMB) that the Company may move forward to the Phase II stage of the trial...The Phase I/II multi-center clinical trial is composed of two stages. The first stage is a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the target knee in order to identify the dose and injection regimen for the subsequent Phase II stage....The Company expects that the primary measurements will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment."

DSMB • Trial status • CNS Disorders • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology

Apoptotic Cell-Based Therapy for the Modification of the Inflammatory Response to Hemorrhagic Shock. (PubMed, Mil Med) - "In a pressure-control hemorrhagic shock model in rats, apoptotic cell infusion showed preliminary signs of a uniform attenuated cytokine response. Apoptotic cell-based therapies might serve as a novel immunomodulatory therapy for hemorrhagic shock."

Journal • Hematological Disorders • Immunology • Inflammation • Mood Disorders • Oncology • IFNG • IL1B • IL6 • TNFA

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Enlivex Therapeutics Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Enlivex Receives Regulatory Authorization For The Initiation Of A Phase I Clinical Trial To Evaluate Allocetra In Patients With Psoriatic Arthritis (GlobeNewswire) - "Enlivex Therapeutics...announced that the Israeli Ministry of Health has authorized the initiation of a Phase I clinical trial to evaluate the safety and tolerability of Allocetra following injection into an affected joint in patients with psoriatic arthritis. The trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for psoriatic arthritis. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and secondary endpoints will include assessments of change from baseline in pain and other parameters of disease activity for up to 12 months following administration of Allocetra."

New P1 trial • Psoriatic Arthritis

Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint (clinicaltrials.gov) - P1/2 | N=46 | Recruiting | Sponsor: Kaplan Medical Center

New P1/2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy (clinicaltrials.gov) - P1/2 | N=14 | Terminated | Sponsor: Enlivex Therapeutics RDO Ltd. | N=72 ➔ 14 | Trial completion date: Dec 2024 ➔ Apr 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Apr 2024; Sponsor decision

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Oncology • Peritoneal Cancer • Solid Tumor

Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis (clinicaltrials.gov) - P1/2 | N=9 | Terminated | Sponsor: Enlivex Therapeutics RDO Ltd. | Trial completion date: Sep 2024 ➔ Mar 2024 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Mar 2024; Sponsor decision

Trial completion date • Trial primary completion date • Trial termination • Oncology

Enlivex Announces Authorization from the Danish Regulatory Agency for the Company’s Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Patients with Knee Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...announced that the Danish Medicines Agency (DKMA) authorized the expansion into Denmark of the Company’s multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis....The Phase I/II multi-center trial is composed of two stages. The first stage is a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the target knee in order to identify the dose and injection regimen for the second, randomized stage."

Trial status • Immunology • Osteoarthritis • Pain

Safety of Repeated Administration of Xenogeneic Human Apoptotic State (Allocetra-OTS) in Sprague Dawley Rats. (PubMed, Pharmaceutics) - "Splenomegaly and dose-related extramedullary hematopoiesis (EMH) in the red pulp were observed, with no adverse events, and were considered to be a normal and expected reaction following the IV administration of cell-based therapies. In conclusion, under the conditions of this study, Allocetra-OTS was concluded to be safe, further supporting its potential candidacy for clinical studies."

Journal • Preclinical • Hematological Disorders • Ophthalmology

A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Enlivex Therapeutics Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2024 ➔ Dec 2024

Enrollment closed • Trial primary completion date • Gastroenterology • Hepatology • Infectious Disease • Nephrology • Pneumonia • Respiratory Diseases • Septic Shock

A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P2 | N=12 | Terminated | Sponsor: Enlivex Therapeutics Ltd. | Phase classification: P2b ➔ P2 | Trial completion date: Sep 2023 ➔ Mar 2024 | Active, not recruiting ➔ Terminated; strategic reprioritization

Phase classification • Trial completion date • Trial termination • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases