Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR) today announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company's planned clinical development program for PLX-PAD.

Based on positive feedback from the EMA and FDA, Pluristem feels that it is now in a position to advance towards two clinical studies with its PLX-PAD cells: a joint FDA-EMA Phase II/III study of PLX-PAD for CLI and a Phase II study for IC under the FDA and the Paul Ehrlich Institute (PEI), the German competent authority in the European Union.

"PLX-PAD has shown promise throughout its initial clinical development, and I am pleased that both the EMA and FDA have acknowledged our proposed comprehensive clinical development plan, which may lead to an advanced cell therapy product that could help millions of PAD patients.

"The completion of two Phase-I CLI clinical studies, performed in parallel in Germany and the U.S., placed Pluristem in a unique position to discuss with the regulatory agencies an approach that should allow a single clinical study protocol to be accepted by both agencies," commented Zami Aberman, Chairman and Chief Executive Officer of Pluristem.

 "What is particularly exciting about this development," continued Aberman, "is that it places us -- for the first time -- on-track for a potentially preventative treatment for PAD in addition to treating amputation-destined cases."

"PLX-PAD has shown an early read-out of efficacy throughout its clinical development and I am pleased that PLX-PAD has made the necessary progress from a regulatory perspective, to move forward with advanced trials," commented Edwin Horwitz, MD, PhD, President of the International Society for Cell Therapy, and the head of Pluristem's scientific advisory board. "I am excited that the PLX-PAD clinical trials will be conducted in the EU and the U.S. under the same clinical protocol, bringing the therapy closer to market and to those CLI patients in need of improved therapies."

The EMA and FDA concurred on the main protocol design elements. The Phase II/III clinical trial will be a multinational, multicenter, randomized, double-blind, placebo control, parallel study. Patients with CLI, Fontaine class III-IV, Rutherford category 4-5, will be enrolled and treated with two PLX-PAD treatments or with two placebo treatments, a few months apart. PLX-PAD or placebo will be administered via multi-intramuscular injections delivered to the affected leg.

The primary endpoint of the study will be major-amputation free survival rate (amputations and death) at 12 months from the initial treatment with PLX-PAD or placebo.

SOURCE Pluristem Therapeutics Inc.