JERUSALEM, ISRAEL -- Enlivex Therapeutics (Enlivex), a Hadasit Bio-Holdings (HBL, TASE: HDST / OTCQB: HDASY) portfolio company, today announced that the European Medicines Agency (“EMA”) has granted orphan drug status to the Company’s lead product candidate, ApoCell, for the prevention of Graft-versus-host Disease (GvHD). Previously, ApoCell received orphan drug designation from the U.S. Food & Drug Administration (FDA). The Company plans to initiate a Phase IIb / III trial of ApoCell in GvHD in 2015.
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GvHD is a complication of allogenic (donor-based) bone marrow and stem cell transplants in which the newly transplanted cells recognize the recipient as foreign and attack the body. GvHD can damage organs including the liver, skin and digestive tract. With no effective cure for GvHD currently available, the most common therapy is Immunosuppression, including steroid treatment, which can significantly increase the patient’s risk of severe infection.
Tami Kfir, CEO of Hadasit Bio-Holdings added, “We are extremely pleased with the progress that Enlivex has made since Professor Mevorach first discovered the ApoCell technology, including the receipt of orphan drug status in the United States in 2013. With compelling Phase I/II data, which demonstrated a significant reduction in acute (grade II – IV) GvHD in patients treated with ApoCell, we believe that ApoCell has great potential in the GvHD market, which is projected to reach $600 million in 2018. In addition to extended market exclusivity, this orphan drug designation could accelerate the EMA regulatory process and significantly reduce time-to-market for ApoCell in Europe. We look forward to sharing details of future Enlivex milestones in the ongoing GvHD development program and other autoimmune and inflammatory indications.”
