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The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.
Pluristem Therapeutics, Inc. has been in detailed discussions with Europe’s Adaptive Pathways Discussion Group regarding the clinical development of its placenta-based cell therapy products (PLX cells) for treatment of critical limb ischemia (CLI) and other illnesses.
The company has received guidance on design for initial Phase II trials in a subgroup of patients with severe CLI. If results from this trial are positive, Pluristem could receive conditional approval to commercialize the cells for this treatment, accelerating the move from lab to market.
European regulators are offering this guidance because PLX cells were selected for study by the European Medicine Agency's Adaptive Pathways project back in May 2015.
Pluristem also discussed potential Adaptive Pathways development for PLX cells in treatment of ischemic stroke, muscle wasting, hip fracture, and additional subgroups of CLI.
Adaptive Pathways is part of a European Medicine Agency's (EMA) program to speed up and improve access to new therapies that target unmet medical needs. The goal is to reduce the time to a medicine's approval or to its reimbursement for targeted patient groups.