HAIFA, ISRAEL, May 18, 2015 —Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR),a leading developer of placenta-based cell therapy products, today announced a significant advancement to its clinical development plan: the PLX cell program in critical limb ischemia has been selected for the European Medicines Agency’s Adaptive Pathways pilot project. The goal of the project is to improve timely access for patients to new medicines. It allows for early marketing authorization of a therapy in a restricted patient population, followed by additional assessments and the possibility of later approval for use in broader patient populations. Critical limb ischemia (CLI), a severe blockage in the arteries of the legs which markedly reduces blood-flow, is associated with a significantly increased risk of leg amputation and death. It currently affects approximately one million people in the U.S., and the prevalence is expected to increase significantly in the coming decades. CLI therefore represents a major commercial opportunity. Acceptance of Pluristem’s cells for the treatment of CLI into the Adaptive Pathways could significantly curtail the time and investment needed to bring this product to market.
“Acceptance into Europe’s Adaptive Pathways pilot project is a tremendous milestone for Pluristem. It allows us to potentially commercialize our product earlier than expected,” stated Pluristem CEO Zami Aberman. “We are extremely pleased with this outcome, which was one of the key elements we defined in our long term strategy to lead the cell therapy industry. Reducing time to market is a critical element of our strategy. The Adaptive Pathways has the potential to assist us in accomplishing this goal.” Mr. Aberman added, “last week we announced a milestone in Japan, which is also an important territory for us. We are pursuing our strategy for expedited approval of PLX cells in Japan. We have applied to Japan’s Accelerated Pathway for Regenerative Medicine for our PLX cells in critical limb ischemia, and Japan’s Pharmaceuticals and Medical Devices Agency just validated the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials.”
Pluristem has already amassed experience in working with the European Medicines Agency and conducting trials in the EU. The Company completed both a Phase I trial in CLI and a Phase II trial in muscle injury in Europe. Pluristem is currently conducting a multinational Phase II trial in intermittent claudication, the less advanced stage of peripheral artery disease that can precede CLI, and several of the trial sites are located in Europe. Pluristem has also effectively protected its IP in Europe. In October 2014 Pluristem successfully defended a European Patent whose claims cover treatment of ischemia with adherent placental cells which are propagated using a 3D culture. CLI is a type of ischemic disease, so the potential future treatment of CLI with PLX cells is protected by this robust European patent.