February 1, 2015 | Enlivex Therapeutics announced that the European Medicines Agency granted orphan drug status to ApoCell. The drug, which received orphan drug status from the US Food & Drug Administration in 2013, is Enlivex’s lead drug candidate for prevent of Graft-versus-host Disease (GVHD). “The EMA’s orphan drug designation of ApoCell is a significant step forward in our clinical program. GvHD is a serious complication that affects 30% – 70% of bone marrow transplant patients and a substantial contributor to transplant-related morbidity and mortality,” said Alon Moran, CEO of Enlivex. Now the company plans to initiate Phase IIb/ III clinical trials on ApoCell in 2015. A Hadasit Bio-Holdings portfolio company, Enlivex develops immunotherapy treatments for autoimmune and inflammatory conditions by inducing immune tolerance.