Pluristem Receives U.S. FDA Clearance for Phase II Clinical Trial in Intermitten Claudication ($PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory 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 or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market. 

Pluristem Theapeutics announced that the FDA has approved the commencement of Phase II clinical trials of PLX-PAD cell product candidate for the treatment of a form of peripheral artery disease, Intermittent Claudication (IC).  This trial will investigate the safety and effectiveness of of PLX-PAD cells versus placebo.  

Zami Aberman, Chairman and CEO of Pluristem, commented,

"We are excited to receive the world's FDA first clearance for an Intermittent Claudication clinical trial using allogeneic cell therapy as a potential preventive treatment for IC. We believe that our approach of repeatable intramuscular injections will potentially enable us to boost the healing process of our patients. In this trial, we will take benefit of our 'off-the-shelf' PLX properties achieved by our three dimensional (3D) proprietary technology platform for efficient, controlled, mass production of cell therapy product candidates, for the treatment of millions of IC patients around the world."

Read the full press release here.