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Israel-based Enlivex Therapeutics has completed enrollment of all subjects in the Phase II stage of its Phase I/II trial of the off-the-shelf cell therapy Allocetra, targeting moderate to severe knee osteoarthritis.
In this stage, more than 133 subjects were randomised and treated.
The randomised, multi-centre trial is structured in two stages. The initial Phase I stage was an open-label, dose-escalation phase focusing on the safety and tolerability of the cell therapy injections into the knee.
The outcomes from this stage were used to determine the dosage and injection regimen for the following Phase II stage.
Enlivex reported positive interim three and six-month efficacy data from the first 12 subjects in the Phase I stage, showing improvements in the main efficacy endpoints without safety concerns.
The placebo-controlled, double-blind trial Phase II stage not only continues to assess safety but also includes an interim statistical assessment by an independent third party and is blinded to Enlivex.
This evaluation will determine the potential benefits of increasing the patient cohort by up to 50 additional participants and its effect on the statistical significance of the results.
An independent data safety and monitoring board (DSMB) is also in place to review safety data at predetermined intervals.
The trial's primary efficacy endpoints will assess joint pain and function against a placebo at three, six and 12 months after the treatment.
Enlivex anticipates releasing topline data from the Phase II stage, including full three-month endpoints, by August this year.
Enlivex Therapeutics CEO Oren Hershkovitz said: “We are pleased to have completed the recruitment of patients in the Phase II stage of this trial, which follows the recently announced promising initial efficacy data from the Phase I stage.
“We believe Allocetra has the potential to transform the way osteoarthritis patients are being treated today, and we are eager to receive the topline data of the trial.”
In December 2024, the company received approval from the Israeli Ministry of Health to initiate a Phase I trial of Allocetra in patients with temporomandibular joint osteoarthritis.
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"Enlivex enrols all patients in Phase II stage of knee osteoarthritis trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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