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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
Enlivex Therapeutics (Nasdaq: ENLV) has received regulatory approval from the Israeli Ministry of Health to initiate a Phase I/II trial of Allocetra™ for thumb osteoarthritis. This is the first study of Allocetra™ in thumb osteoarthritis, following previous studies in knee osteoarthritis. The trial will be led by Dr. Amir Oron and aims to evaluate the safety, efficacy, and tolerability of Allocetra™ in up to 46 patients who have failed conventional therapies. The trial consists of two stages: an open-label dose escalation phase and a double-blind, placebo-controlled phase. The primary endpoints will measure safety and efficacy over 12 months. Enlivex aims to expand its osteoarthritis clinical programs into additional joints.
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