Enlivex Therapeutics Ltd. 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 treatment. Recruitment to the study and long-term follow up are ongoing. The study aims to enroll a total of 18 patients to be treated with a single injection of AllocetraTM to the afflicted knee.

Patients are assessed for safety following dosing, and pain and function responses to treatment up to 12 months following injection.