Hadasit Bio co obtains FDA orphan drug status

Enlivex Therapeutics is developing Apocell for treating graft-versus-host disease in bone marrow transplants.

Hadasit Bio Holdings Ltd. (TASE:HDST; Bulletin Board: HADSY) portfolio company Enlivex Therapeutics Ltd. has obtained orphan drug status from the US Food and Drug Administration (FDA) for its Apocell treatment for graft-versus-host disease (GVHD). GVHD affects 70% of patients who receive bone marrow transplants from an unrelated donor, and can be lethal.

"The main achievement of orphan drug status is the seven years exclusivity, guaranteeing no competition irrespective of patents, and significant regulatory easements, which we believe will shorten marketing approval of the drug in the US, reducing costs," said Enlivex CEO Alon Moran.

"The results of clinical trials of Apocell showed strong efficacy and safety indications of the treatment, which allows transplants from unrelated donors while minimizing severe GVHD complications. We intend to pursue development of the drug from a Phase IIb clinical trial through full marketing approval in the US."

GVHD affects 30,000 people annually in the US and Europe. It is basically an autoimmune disease, in which the body's immune system attacks the implant as a foreign body. There is no effective treatment for the disease. Current treatments involve suppressing the body's immune system, but this exposes patients to disease.

Apocell induces tolerance in the patient's immune system by activating the natural cell death mechanism, apoptosis, immediately after a bone marrow transplant.

"FDA orphan drug status for Enlivex's Apocell is important regulatory recognition of the drug's necessity," said Hadasit Bio CEO Ophir Shahaf.

Hadasit Bio, a unit of Hadasit - the Technology Transfer Company of Hadassah Medical Organization , owns 92% of Enlivex. Hadasit Bio's share price rose 23.5% by early afternoon on the TASE to NIS 0.358, giving a market cap of NIS 45 million. The share closed at $1.60 on the Bulletin Board yesterday.

Published by Globes [online], Israel business news - www.globes-online.com - on April 3, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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