Enlivex announces enrollment, dosing of first 10 patients in Allocetra trial

Enlivex Therapeutics (ENLV) announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of the Company’s multi-country Phase I/II Allocetra trial in patients with moderate to severe knee osteoarthritis. The initiation of patient dosing follows the recently announced recommendation by the independent Data and Safety Monitoring Board to proceed with the randomized Phase II stage at the highest tested dose, as well as the Danish Medicines Agency’s authorization to initiate this next trial stage. The multi-center Phase I/II clinical trial consists of two stages. The first stage, which was successfully completed, was a Phase I 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 subsequent Phase II stage. The Phase II stage is a double-blind, randomized, placebo-controlled stage. In addition to evaluating safety, the blinded randomized stage is statistically powered to assess the efficacy of Allocetra injections into the knee. The trial’s key efficacy end points will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.