Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [4] Clinical Trial Progress - The independent Data and Safety Monitoring Board (DSMB) has completed an interim data review of the Phase I safety run-in stage of the Phase I/II clinical trial for Allocetra™ in up to 160 patients with moderate to severe knee osteoarthritis [1] - No serious adverse reactions were reported during the Phase I safety run-in, allowing the company to proceed to the Phase II stage, which will be a double-blind, randomized evaluation of Allocetra™ injections compared to placebo [1][2] - The Phase I/II trial consists of two stages: the Phase I safety run-in to assess safety and tolerability, followed by the Phase II stage to evaluate efficacy and safety in a controlled setting [2] Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [3] - The condition leads to significant disability, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes, and it accounts for over one million hospitalizations annually in the U.S. [3] Treatment Landscape - Currently, there are no FDA or EMA approved medications that can arrest, slow, or reverse the progression of structural damage in osteoarthritis, highlighting the critical need for effective treatments [3]
Enlivex Announces Positive DSMB Recommendation to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis