Pluristem Announces Key Discussions With Europe's Adaptive Pathways Group on Phase II Protocol in CLI

Pluristem Therapeutics Inc.

today announced that it has conducted detailed discussions with the European Adaptive Pathways Discussion Group regarding the clinical development plan for PLX cells in Critical Limb Ischemia (CLI) patients, and received guidance on the planned design of the initial Phase II trial of PLX cells in a subgroup of patients with severe CLI. Positive results from this trial could be sufficient for conditional approval to market PLX cells in this indication. Pluristem is receiving this in-depth guidance from European regulatory officials following the selection of this clinical program for the European Medicine Agency's Adaptive Pathways project in May 2015. In the discussions Pluristem also presented other indications for potential development through the Adaptive Pathways project; these were ischemic stroke, muscle wasting, hip fracture and additional subgroups of CLI. The Adaptive Pathways project is part of the European Medicine Agency's (EMA) efforts to improve timely access for patients to new therapies. It targets treatments with the potential to heal serious conditions with an unmet medical need, and may reduce the time to a medicine's approval or to its reimbursement for