Enlivex Therapeutics announces FDA clearance of Allocetra new drug application

Enlivex announced that the FDA has cleared its investigational new drug application for Allocetra, the company’s clinical-stage immunotherapy, for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis. The FDA’s clearance enables Enlivex to initiate a global, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial designed to evaluate the efficacy and safety of intra-articular injections of Allocetra in patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis.