Enlivex Therapeutics receives IMOH regulatory authorization

Enlivex Therapeutics announced that the Israeli Ministry of Health, IMOH, authorized the initiation of a Company-sponsored multi-country, double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra following injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients. 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 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 safety and tolerability independent Data Safety Monitoring Board.