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Enlivex Announces Positive Interim Data Readout from a Phase I/II Trial Evaluating Allocetra in End-Stage Knee Osteoarthritis
Key Highlights Enrolled patients with severe knee osteoarthritis who were indicated for knee-replacement surgery received a single local injection of
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[{"type":"text","content":"Key Highlights Enrolled patients with severe knee osteoarthritis who were indicated for knee-replacement surgery received a single local injection of AllocetraTM into the knee as a “last resort”Three-month data readout showed a significant reduction in pain and a favorable safety profile Pain reduction: patients reported an average pain reduction of 64% from baselineComplete Pain Resolution: 33% of patients reported complete pain relief, from an average pain level of 9 to a pain level of 0; pain scale used in the study ranged from 0 (no pain) to 10 (maximum pain)Avoidance of Surgery: 89% of patients did not proceed with knee replacement surgery at three months post-injectionSafety: No severe adverse events related to Allocetra™ were reported Ness-Ziona, Israel, June 17, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the \"Company\"), a clinical-stage macrophage reprogramming immunotherapy company, today released a positive interim data readout from a Phase I/II investigator-initiated clinical trial of AllocetraTM in patients with end-stage knee osteoarthritis who had been indicated for knee replacement surgery. In this study, patients with end-stage knee osteoarthritis are offered a single AllocetraTM injection to the knee as a potential “last resort” alternative for pain resolution and knee functionality in lieu of knee-replacement surgery. A total of nine patients have been enrolled and treated with a single AllocetraTM injection to the knee and evaluated for at least three months following treatment. Patients reported pain using a scale of zero (0, representing no pain) to ten (10, representing maximum pain). At the three-month follow up, a substantial reduction (64%) in average reported pain was observed compared to baseline (Figure 1), with 89% (8/9) of treated patients reporting an improvement in their knee pain compared to their baseline pain prior to treatment, and 33% (3/9) of the patients reporting complete pain relief from an average pain level of 9 to a pain level of 0. During the three-month period post injection of AllocetraTM, only a single patient (1/9, 11%) decided to move forward with knee-replacement surgery, while 89% (8/9) of the patients decided not to proceed with such surgery. In all cases, dosing was successfully completed, and no severe related adverse events were reported following t...