Enlivex Therapeutics has published a scientific paper in the American Society for Blood and Marrow Transplantation titled “Biology of Blood and Marrow Transplantation.”
The peer-reviewed paper provides additional validation to the phase I/II results and emphasizes the significance of its findings. The findings were based on a 13 patient trial conducted in three clinical centers in Israel.
The patients were given four escalating doses of ApoCell, Enlivex's lead product, shortly before a bone marrow transplant from a foreign donor. No safety concerns were observed in any of the doses and GvHD morbidity levels were significantly reduced.
One of the main concerns in receiving bone marrow transplants from a donor is Graft-versus-Host Disease (GvHD). GvHD is an auto-immune type disease in which the immune system, including the new transplant, attacks organs of the patient, primarily the liver, intestines and skin. The disease can cause significant morbidity and is usually fatal if a patient reaches high grades.
To date, no effective treatment has been found for this disease and up to 70% of transplant recipients suffer from this illness.
ApoCell is based on a cellular treatment developed in Hadassah Ein Kerem by Prof. Dror Mevorach, who has experience in diseases of the immune system. The treatment is based on normal biological activity and initiates a state of “immune tolerance” allowing the implant to fight the patients' cancer while significantly reducing the GvHD severity.
Enlivex Therapeutics recently was awarded Orphan Drug status by the FDA for its ApoCell treatment. The Orphan Drug designation provides for seven years of exclusivity, guaranteeing no competition irrespective of patents and significant regulatory relief, which will likely shorten the marketing approval of the drug in the U.S. and reduce costs.