Enlivex Therapeutics (ENLV) announced the issuance of an Israeli patent, numbered 290470, titled, “THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS”. The patent will provide Enlivex with added intellectual property protection in Israel through at least 2040 with claims covering methods of using Allocetra to treat subjects with osteoarthritis. Enlivex recently reported positive three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra in patients with moderate-to-severe knee osteoarthritis. In the overall modified intention-to-treat population, improvements across all efficacy and secondary endpoints, including 24% reduction in knee pain and 26% improvement in knee function, were observed in the Allocetra treatment arm vs placebo; moreover, 72% reduction in knee pain and 109% improvement in knee function were observed for age-related primary osteoarthritis patients compared with placebo – a substantial, clinically meaningful and statistically significant effect in commonly used Phase III primary endpoints for knee osteoarthritis clinical trials.
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