08:26 AM EDT, 04/16/2024 (MT Newswires) -- Enlivex Therapeutics ( ENLV ) said Tuesday that the Danish Medicines Agency has authorized the expansion of its phase 1/2 trial evaluating Allocetra in patients with moderate to severe knee osteoarthritis.
The first stage of the trial will test the safety and tolerability of Allocetra injections to identify the dose and injection regimen for the second, randomized stage, the compani said.
The second stage is a double-blind, randomized, placebo-controlled stage, which Enlivex said it expects to initiate after the safety run-in stage and confirmation by the independent Data and Safety Monitoring Board is completed. The second stage will also evaluate the efficacy of Allocetra injections into the knee, the company added.