125  0 Kommentare Enlivex Receives IMOH Regulatory Authorization for the Initiation of a Multi-Country, Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Up To 160 Patients with Moderate to Severe Knee Osteoarthritis

• Second study of Allocetra in knee osteoarthritis, following the on-going Phase I/II trial in pre-surgery, end-stage osteoarthritis, that is continuing to enroll patients
  

Nes-Ziona, Israel, Jan. 17, 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 (IMOH) authorized the initiation of a Company-sponsored multi-country, double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra following injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients.

The Phase I/II multi-center trial 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 Allocetra injections to the target knee in order to identify the dose and injection regimen for the randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in stage and confirmation by the safety and tolerability independent Data Safety Monitoring Board. On top of evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra injections into the knee. The primary measurements will be comparisons of joint-pain and joint-function compared to placebo at three months, six months and 12 months.

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“Following the enrollment progress of knee osteoarthritis end-stage patients in a Phase I/II investigator-initiated clinical trial, we are now expanding the osteoarthritis vertical to include moderate and severe osteoarthritis patients, who comprise the majority segment of the knee osteoarthritis population” said Einat Galamidi, M.D., Vice President, Medical of Enlivex. “Macrophages are now considered as an emerging therapeutic target in the treatment of osteoarthritis, and the macrophage reprograming mechanism of action of Allocetra positions it as a potentially promising therapy for this substantial unmet life-debilitating indication.”