Pluristem In Talks With Adaptive Pathways Group On Phase II Protocol In CLI

(RTTNews) - Pluristem Therapeutics Inc. (PSTI), a developer of placenta-based cell therapy products, Monday said it conducted detailed discussions with the European Adaptive Pathways Discussion Group regarding the clinical development plan for PLX cells in Critical Limb Ischemia or CLI patients.

The company received guidance on the planned design of the initial Phase II trial of PLX cells in a subgroup of patients with severe CLI.

Pluristem said 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 after the selection of this clinical program for the European Medicine Agency's Adaptive Pathways project in May.

During the talks, Pluristem also presented other indications for potential development through the Adaptive Pathways project, including ischemic stroke, muscle wasting, hip fracture and additional subgroups of CLI.

The Adaptive Pathways project is part of the European Medicine Agency's efforts to improve timely access for patients to new therapies.

The project targets treatments with the potential to heal serious conditions with an unmet medical need, and may reduce the time taken to a medicine's approval or to its reimbursement for targeted patient groups.