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Stock impact report

Enlivex Announces Authorization from the Danish Regulatory Agency for the Company's Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Patients with Knee Osteoarthritis [Yahoo...

Enlivex Therapeutics Ltd. - Ordinary Shares (ENLV) 
Company Research Source: Yahoo! Finance
immunotherapy company, today announced that the Danish Medicines Agency (DKMA) authorized the expansion into Denmark of the Company's multi-country, randomized, controlled Phase I/II trial evaluating Allocetra TM 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 (IMOH) 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, Show less Read more
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