Hadasit Bio-Holdings

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Enlivex Therapeutics Announces Positive Results in Completion of Clinical Trial for the Treatment of Bone Marrow Transplant Recipients

Oct. 24, 2012

Link to Hebrew report

Hadasit Bio-Holdings Ltd. portfolio company completes clinical trial that shows safety and efficacy by significantly reducing the fatal effects of Graft-versus-Host Disease in bone marrow transplant recipients, which currently has no effective treatment.

Jerusalem, Israel – October 24, 2012 – Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel’s foremost medical research center, today announced that its portfolio company Enlivex has completed a clinical trial and is reporting positive results that indicate efficacy and safety in its treatment for recipients of bone marrow transplants from foreign donors. Hadasit Bio-Holdings holds a 92% stake in Enlivex.

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, Enlivex’s lead product, is based on a cellular treatment developed in Hadassah Ein Kerem by Prof. Dror Mevorach, an expert in diseases of the immune system. In the clinical trial, 13 patients in three clinical centers in Israel were given four escalating doses of ApoCell against GvHD shortly before a bone marrow transplant from a foreign donor. An external committee that examined the results of the trials resolved that no safety concerns were observed in any of the doses, and therefore permitted the continuation of the research and treatment of the patients at the maximum dosage tested in the trial.

GvHD severity is classified into four levels that constitute the clinical and regulatory effectiveness index accepted in the field. In a comparison made between the ApoCell trial and a historical control group composed of relevant patients with similar characteristics and treatment background, it was found that the incidence of GvHD grades 2-4, the most dangerous levels of the disease, were reduced by half. Furthermore, among the group that received the higher doses of ApoCell, no cases of GvHD grades 2-4 were observed, while 50% of similar patients who did not receive the ApoCell treatment did develop GvHD grades 2-4. Another promising result witnessed was the protective effect that the treatment provided against liver damage, a major component of GvHD.

Alon Moran, CEO of Enlivex, stated, “We are pleased with the final results of the trial which point to the efficacy and safety of our treatment. It has the potential to allow the performance of a bone marrow transplant from a foreign donor while reducing the serious damage inflicted by GvHD. Not only were these results confirmed by an external committee, but they also showed substantial positive signs for the effectiveness of the treatment, expressed by the reduced levels of GvHD incidence and morbidity. While we must be cautious in analyzing the data, as it represents a relatively small number of patients, we believe that the trial results show real potential for dealing with this serious illness. We look forward to conducting trials in a larger controlled study to further prove the effectiveness of ApoCell.”

Ophir Shahaf, CEO of Hadasit Bio-Holdings, commented, “The success of Enlivex’s trial marks a significant advancement for the company and our portfolio. This is one of the flagship companies of Hadasit as we hold more than 90% of Enlivex and it’s under our close management and financing. The completion of the clinical trial lays the foundation for further advancement of the treatment of GvHD and the potential to tap into a market size estimated at hundreds of millions of dollars per year. We are currently working to locate financial and strategic partners to help us continue development and eventually commercialize the medication.”

Mr. Shahaf concluded, “Our success in trials such as this further validates the amazing science stemming from the Hadassah hospitals. As our portfolio continues to mature, we will provide significant value to our investors.”


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