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Enlivex Receives Regulatory Authorization for the Initiation of a Placebo-Controlled Phase I/II Trial Evaluating Allocetra in Up To 46 Patients with Thumb Osteoarthritis
● First study of AllocetraTM in thumb osteoarthritis, a debilitating disease that affects millions of people in the U.S., and has no FDA-approved therapy
About this update from Enlivex Ltd.
[{"type":"text","content":" ● First study of AllocetraTM in thumb osteoarthritis, a debilitating disease that affects millions of people in the U.S., and has no FDA-approved therapy ●Third study of AllocetraTM in osteoarthritis, following the on-going Phase I/II trial in pre-surgery, end-stage knee osteoarthritis, and the on-going randomized, placebo-controlled Phase I/II trial in up to 160 moderately to severely symptomatic knee osteoarthritis patients Ness-Ziona, Israel, June 03, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health authorized the initiation of an investigator-initiated, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis. The investigator-initiated trial will be led by Amir Oron, M.D., a senior specialist in Orthopedics and Chief of Hand Surgery and Microsurgery at the Kaplan Medical Center in Rehovot, Israel. Dr. Oron stated, “Osteoarthritis of the basal joint of the thumb is a very common disease, and while it can be extremely painful and debilitating, we currently have no truly effective treatments for this disease. We now have become more knowledgeable about the pivotal role that macrophages play in the development and progression of osteoarthritis, and I believe that the unique and innovative mechanism of action of AllocetraTM may be a disease modifying treatment for these patients. I am excited to lead this study and look forward to initiating the trial.” Dr. Oron has a long and successful track record of innovation. He was the first Israeli surgeon who participated in donor-hand transplantation surgery and is an award winner from the American Society for Surgery of the Hand for the development of an innovative tendon repair technique. The investigator-initiated Phase I/II trial plans to recruit up to 46 patients and 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 AllocetraTM injection to patients with osteoarthritis of the first basal thumb joint (first CMC joint) of the target thumb who have failed conventional therapies, to id...