Enlivex Announces Interim Efficacy Data From Allocetra Trial In Patients With Moderate To Severe Knee Osteoarthritis; The Interim Efficacy Results Are Statistically Significant, And Show Marked Improvements In All Key Efficacy Endpoints, Including Reduction Of Pain And An Improvement In Functionality, Compared To Baseline
Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company"))), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive interim efficacy data from the Phase I stage of its randomized, multi-country Phase I/II Allocetra trial in patients with moderate to severe knee osteoarthritis.
The multi-center Phase I/II clinical trial consists of two stages. The first stage, which was successfully completed, was 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 previously announced that no serious adverse reactions were reported during or following treatment in the Phase I stage. The information below details the interim efficacy data with respect to the treatment of these patients, measured three months following the administration of Allocetra injections. The interim efficacy results are highly positive, statistically significant (p-value < 0.0007, n=12), and show marked improvements in all key efficacy endpoints, including reduction of pain and an improvement in functionality, compared to baseline.
