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news.Israel-based Enlivex Therapeutics has received orphan drug status from the European Medicines Agency (EMA) for its lead product candidate, ApoCell, to prevent graft-versus-host disease (GvHD).
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The US Food and Drug Administration (FDA) also granted orphan drug designation for ApoCell).
Enlivex, a Hadasit Bio-Holdings portfolio company, intends to commence a Phase IIb / III trial of ApoCell in 2015 for the treatment of in GvHD, a complication of allogenic bone marrow and stem cell transplants in which the newly transplanted cells recognize the recipient as foreign and attack the body.
Enlivex CEO Alon Moran said: "GvHD is a serious complication that affects 30% – 70% of bone marrow transplant patients and is a substantial contributor to transplant-related morbidity and mortality."
Currently, there is no effective cure for GvHD and the most common therapy is Immunosuppression, including steroid treatment, which can increase the patient’s risk of severe infection.
Hadasit Bio-Holdings CEO Tami Kfir said: "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."