Pluristem Therapeutics Set to Enter Bone Marrow Disease Market as it is Preparing to Apply for Orphan Drug Status With the FDA for the Treatment of Aplastic Bone Marrow

Pluristem Therapeutics, Inc.

today announced it is preparing to apply to the U.S. Food and Drug Administration for approval of its PLacental eXpanded (PLX) cells for the treatment of aplastic bone marrow as an Orphan Drug. Gaining Orphan Drug status approval is part of Pluristem's strategy for penetrating the bone marrow recovery market, starting with treatment of aplastic anemia, a disease in which bone marrow greatly decreases or stops production of blood cells and which strikes five to ten people in every million. Gaining Orphan Drug Status carries multiple potential benefits, including the possibility of an expedited regulatory process, availability of grant money, certain tax credits and seven years of market exclusivity. In August 2011, Pluristem successfully applied for, and received, Orphan Drug Status from the FDA for its PLX cell therapy in the treatment of Buerger's disease. Pluristem announced earlier this year that its PLX cells had saved the life of a seven year-old girl suffering from aplastic bone marrow and who had undergone two failed bone marrow transplants. With her condition rapidly deteriorating, her doctors injected Pluristem's PLX cells intramuscularly, following which the girl experienced a reversal of her condition with a significant increase in her red blood cells, white blood cells and platelets.