Significant short and long-term clinical improvement for a hospitalized patient with a rare disease that currently has no effective treatment options *
Nes Ziona, Israel, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the ", Company", ))))), a clinical-stage immunotherapy company, today reported a positive two-year clinical outcome following the first Allocetra™ treatment of a hospitalized patient with erosive osteoarthritis, a rare bone disease, which has no approved nor effective treatment options and typically involves rapid destruction of hip and shoulder bones. This was the sole erosive osteoarthritis patient who has been treated with Allocetra™ to date.
A 70-year-old patient experienced a four-year inflammatory and erosive process of the right shoulder, resulting in complete destruction of the humeral head on X-ray, significant inflammatory reaction on MRI, and significantly elevated inflammatory biomarkers in the shoulder, including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Following regulatory approvals for compassionate use, the patient was treated with five consecutive weekly intra-shoulder joint infusions of autologous Allocetra™ (100 x 106 cells). Prior to receiving AllocetraTM, the patient had been hospitalized for more than nine months, and treatments with steroids, antibiotics and other procedures had been ineffective.
Following AllocetraTM treatment, the patient improved considerably and was released from the hospital following the initial administration of AllocetraTM. A significant reduction in shoulder swelling was observed, with fluid drainage from the shoulder declining from 150–250 ml/day to <60 ml/day. CRP declined by 93%, from 7.34 pre-treatment, to 0.49 after treatment, which is within the normal range. Pro-inflammatory cytokines and chemokines within the treated shoulder joint that are related to monocyte, macrophage, dendritic cell, osteoclast, neutrophil, and T cell activation were downregulated, most notably IL-22 (a marker of dysregulation of wound healing of synovial tissue), IL-8 (a neutrophilic chemotactic factor), IL-6 (a marker of innate immunity), IL-9 (a marker of apoptosis prevention) and MIP-1-beta (a marker of chronic inflammation).
At a 24-month follow-up, the patient's CRP level in the diseased shoulder remained within normal range. The shoulder remained without swelling, and the clinical improvement was maintained without any need for drainage or re-hospitalization during the 24-month period following the Allocetra™ treatment.
Dror Mevorach, Chief Medical Officer of Enlivex, stated, "These results are encouraging, demonstrating the potential of Allocetra™ as a solution for a variety of clinical indications that may be characterized by local intra-joint cytokine storms or dysregulations that still remain without any effective treatment. Joint-related diseases that are considered unmet medical need range from rare diseases, such as erosive osteoarthritis, to osteoarthritis, which affects more than 30 million people in the U.S. alone. We believe that the long-term effect of a single five-week course of Allocetra™ treatment on this erosive osteoarthritis patient was remarkable."
AllocetraTM is currently being evaluated in clinical studies in other diseases related to hyper-expression of cytokines such as sepsis and COVID-19. Enlivex recently reported positive top-line results from a Phase Ib investigator-initiated clinical trial of AllocetraTM in COVID-19 patients in severe and critical condition in Hadassah Hospital, one of the largest hospitals in Israel. The Phase Ib clinical trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients completely recovered from their respective severe/critical condition and were released from the hospital after an average of 5 days (severe) and 9 days (critical), following administration of AllocetraTM, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of AllocetraTM in the patients, and the therapy was well-tolerated.