Pluristem Reports Status of Orphan Drug Application for Aplastic Anemia
FDA Acknowledges Aplastic Anemia as Rare Disease and Requests Further Data From the Company in Connection With Application
HAIFA, Israel, Nov 21, 2012 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has updated the Company on its application to designate Pluristem's PLacental eXpanded (PLX) cells orphan drug status in the treatment of aplastic anemia. The FDA acknowledged that aplastic anemia is a rare disease with prevalence in the United States of less than 200,000. This serves as confirmation that aplastic anemia is an indication for which candidate treatments are eligible for orphan drug status. The FDA has also requested that Pluristem provide additional information and data for further analysis before the FDA can determine if the PLX cells can qualify for orphan drug designation for aplastic anemia.
"We look forward to providing the additional information that the FDA needs in connection with our orphan drug status application for Aplastic Anemia. We appreciate the very productive working relationship we have with the FDA, as we present PLX cells as candidates for the treatment of a range of therapeutic indications," stated Zami Aberman, Chairman and CEO of Pluristem.
About Orphan Drug Status
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.
About Pluristem Therapeutics Inc.
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the use of PLX cells administered locally to treat systemic diseases and potentially obviating the need to use the intravenous route.
Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities as well as strategic relationships with major research institutions.
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