Pluristem Pursues Trials for PLX-PAD Cells to Treat CLI in Japan and Europe

August 12, 2015—Pluristem Therapeutics Inc. announced that Japan's Pharmaceuticals and Medical Devices Agency has cleared the company’s PLX-PAD (placental expanded–peripheral artery disease) cells for use in clinical trials in Japan. On August 10, Pluristem Therapeutics announced that it had 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-2 trial of PLX cells in a subgroup of patients with severe CLI.

The company explained that its PLX cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. The PLX cell products are grown using the company's three-dimensional expansion technology. They can be used "off the shelf," requiring no tissue matching before administration.

The Japanese regulatory clearance allows the company to apply for approval to conduct a phase-2 study of PLX-PAD in CLI through Japan’s accelerated regulatory pathway for regenerative medicine. This regulatory pathway generally allows for conditional, time-limited marketing approval after a single successful phase-2 trial. Safety clearance is the second of three authorizations required by the Japanese Pharmaceuticals and Medical Devices Agency before commencement of a phase-2 trial. Pluristem received the first of these in May 2015, when the agency accepted PLX-PAD cells’ quality standards and large-scale manufacturing methods. The third and final step, which is yet to be achieved, is approval of the clinical study design, advised the company.

Pluristem Therapeutics anticipates receiving permission to begin the Japanese phase-2 trial of PLX-PAD in CLI by the end of 2015 and potentially starting a trial in early 2016.

According to the company, positive results from the European trial could be sufficient for conditional approval to market PLX cells for this indication. Pluristem is receiving 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 2015. In the discussions, Pluristem also presented other indications for potential development through the Adaptive Pathways project; these included ischemic stroke, muscle wasting, hip fracture, and additional subgroups of CLI patients.

The Adaptive Pathways project is part of the European Medicine Agency’s 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 targeted patient groups, stated Pluristem Therapeutics.