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Enlivex Therapeutics Ltd. Publishes Positive Results from Phase I/II Clinical Trial for the Treatment of Bone Marrow Transplant Recipients



11/4/2013 10:13:56 AM

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JERUSALEM, Nov. 4, 2013 /PRNewswire/ -- 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 published a scientific paper in the official publication of the American Society for Blood and Marrow Transplantation - 'Biology of Blood and Marrow Transplantation'. Hadasit Bio-Holdings holds a 92% stake in Enlivex.

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, an expert 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.

Alon Moran, CEO of Enlivex, stated, "We are very proud of this recognition by a leading journal in the field of bone marrow transplantation and believe this direct exposure to the scientific and medical community will increase awareness of our novel and effective treatment for GvHD."

As previously reported, Enlivex Therapeutics was recently 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.

Ophir Shahaf, CEO of Hadasit Bio-Holdings, commented, "This is an outstanding scientific achievement in showing Enlivex's potential but more importantly, validating ApoCell's safety and efficacy in preventing a disease that has no cure. The next step in drug development will be a Phase II/b under an IND from the FDA. We continue to garner interest from a number of parties as we develop this treatment for a market estimated at hundreds of millions of dollars a year."

For more information about Enlivex and ApoCell please visit: www.enlivexpharm.com

For more information about Hadasit Bio-Holdings please visit: www.hbl.co.il

Contact:
KCSA Strategic Communications
Phil Carlson / Josh Dver
212-896-1233 / 1239
pcarlson@kcsa.com / jdver@kcsa.com

SOURCE Hadasit Bio-Holdings Ltd.



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