Friday, Pluristem Therapeutics, Inc. announced that their PLX cells had been designated with orphan status by the FDA for the treatment of thromboangiitis obliterans, or Buerger’s disease. The designation took place several days earlier, on August 22.
Pluristem is a developer of standardized cell therapy products for the treatment of life threatening diseases. Their PLX platform is used as a drug delivery system that releases proteins that take effect on inflammatory diseases in patients. Cells used in the process are grown in a 3D micro-environment that requires no tissue matching. Testing has shown that PLX cells may be effective against nerve pain, muscle damage, inflammatory bowel disease, muscular dystrophy and stroke.
Buerger’s Disease is a rare condition that affects the blood vessels of a patient’s extremities. The resultant clotting and inflammation causes a reduced blood flow to the affected area, and can lead to pain, ulcers and necrosis, requiring amputation. The disease currently affects nearly 50,000 patients through the U.S. and Europe, with no treatment available. It is estimated that the market for a drug that can combat Buerger’s could be worth $2.5 billion.
Pluristem is also pursuing an application in Europe at the EMA’s Committee for Orphan Medicinal Products.
Zami Aberman, Chairman, President and CEO of Pluristem said, “We are extremely pleased that our PLX cells have been designated orphan status by the FDA and look forward to receiving a similar designation in Europe. In anticipation of this designation, we have been working diligently in readying
clinical sites, primarily in India, where there is a high prevalence of Buerger’s. In addition, the inclusion of Buerger’s completes our plan to make our PLX cells available for the entire spectrum of peripheral vascular disorders and allows us to benefit from the market exclusivity and other regulatory and
financial advantages that accompany this designation.”
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