Pluristem Announces Significant Advancement to its Clinical Development Plan

Pluristem Therapeutics Inc. (PSTI) recently 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 1 million people in the US, 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,” said 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. 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.

CLI is a chronic condition caused by a severe compromise of blood flow to the leg that is usually due to narrowing of the arteries as a result of the buildup of fatty deposits called plaque. Complications of this poor circulation can include gangrene and amputation of the affected limb. Estimates of the economic burden of CLI patients exceeds $10 billion dollars annually in the US alone because of the high incidence of limb loss and need for major amputation. Current therapies have many limitations, especially in patients who cannot undergo angioplasty or surgery for revascularization. Anticipated increases in the incidence of CLI will likely generate an expanding market for innovative therapies such as PLX cells.

The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways group conducts high-level discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial targeting early approval and further expansion of the indications.

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the company’s proprietary 3D expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration. For more information, visit www.pluristem.com.