Enlivex announces DKMA authorization for Phase I/II trial of allocetra

Enlivex Therapeutics announced that the Danish Medicines Agency authorized the expansion into Denmark of the Company’s multi-country, randomized, controlled Phase I/II trial evaluating Allocetra in up to 160 patients with moderate to severe knee osteoarthritis. As previously announced, the Company received its first regulatory approval for this trial from the Israeli Ministry of Health in January. 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. The second stage is a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in stage and confirmation by the independent Data and Safety Monitoring Board. In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra injections into the knee. 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.