Shares of Pluristem Therapeutics (NASDAQ: PSTI) are up 7% mid-morning following news that the FDA has cleared the company’s phase 3 study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI). Patients with CLI are at an immediate risk for limb amputation and death, and with meager treatment options, have a severe unmet medical need. The company said it intends to use the results of its study to submit a biologics license application to the FDA for marketing approval. The study is expected to begin patient enrollment in both the U.S. and Europe by June 2017. “We are excited to have received FDA clearance to initiate our phase 3 study for this very important indication. Our PLX-PAD product candidate provides hope for a new, effective treatment and a better quality of life for millions of CLI patients. Pluristem is committed to advancing its peripheral artery disease programs in CLI and intermittent claudication (IC) worldwide,” Pluristem chairman and CEO Zami Aberman stated in the news release.
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About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The different cell products each release their own range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. No tissue matching is required to administration of PLX cell products. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. To learn more visit www.pluristem.com
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