Pluristem Receives FDA Orphan Drug Status Designation for Treatment of Aplastic Anemia Print
By Staff and Wire Reports   
Thursday, 21 February 2013 03:39

icon_fdaheadlinePluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has designated Pluristem's PLacental eXpanded (PLX) cells orphan drug status for the treatment of aplastic anemia.

Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended. These benefits include a 7-year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants.

This is Pluristem's second orphan drug designation from the FDA. The company also received orphan drug status from the FDA for its PLX cells for the treatment of Buerger's disease in August of 2011.

Aplastic anemia is a rare but serious disorder with a prevalence of less than 200,000 in the U.S. The disease is caused by the failure of hematopoietic stem cells (HSCs) contained within the bone marrow to produce red blood cells, white blood cells and platelets. The disease is considered an emergency and patients are supported with blood products in anticipation of a bone marrow transplant (BMT) or drugs that suppress the immune system.

"Receiving orphan drug designation for aplastic anemia is an important event for Pluristem as it open pathways for using our PLX cells for additional indications in the field of hematology," stated Zami Aberman, Chairman and CEO of Pluristem.

Pluristem has established clinical advisory board made up of key opinion leaders in the area of bone marrow transplantation from the United States, Europe and Israel to provide the company with valuable insight towards expanding its activities in the treatment of the bone marrow diseases and transplantations.

Biotech traders are also expecting other significant catalysts for the HAIFA, Israel, based firm in the short term. We would urge readers to keep PSTI shares on watch.

 




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