Pluristem: Japan Clears PLX-PAD Cells For Use In Clinical Trials- Quick Facts

(RTTNews) - Pluristem Therapeutics Inc. (PSTI), an Israeli developer of placenta-based cell therapy products, announced Wednesday that Japan's Pharmaceuticals and Medical Devices Agency or PMDA has cleared the company's PLX-PAD cells for use in clinical trials in Japan.

This clearance is required in order to apply for approval to conduct a Phase II study of PLX-PAD in critical limb ischemia or 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 II trial.

Japan's Act on the Safety of Regenerative Medicines went into effect in November 2014. It effectively fast-tracks the approval of cellular therapies and other regenerative medicine treatments for marketing. No formal Phase III trial is expected to be required.

Pluristem CEO Zami Aberman, said, "Our next step is to conclude the discussion of the clinical protocol with the PDMA for our proposed Phase II CLI study. We expect to talk with the PDMA during the last quarter of 2015, and are anticipating that we will receive permission to begin the trial by the end of 2015. This approval would enable us to potentially start a trial in early 2016."

Safety clearance is the second of three authorizations required by the PMDA prior to commencement of a Phase II trial. Pluristem announced that it 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, yet to be achieved, is approval of the clinical study design.