Pluristem’s goal is to provide patients, doctors and healthcare systems around the globe with standardized, easy to use, and highly effective PLX cell products that need no genetic or tissue matching prior to administration. Part of our clinical development strategy is to achieve product approval through rapid regulatory pathways wherever possible. So far, our clinical development program for PLX-PAD in Critical Limb Ischemia (CLI) is progressing via advanced regulatory opportunities in Europe and Japan.
We intend to partner with pharmaceutical companies to complete regulatory approval and marketing of PLX-PAD in CLI in the U.S., Europe and Japan, and anticipate building on the significant results of our successful Phase II trial in muscle injury to advance development of PLX-PAD for an orthopedic indication in collaboration with a partner as well.
PLX-R18 is also in development for Acute Radiation Syndrome, in collaboration and with the support of the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID). Pending successful completion of a dose selection trial and a pivotal trial by the NIAID, and approval by the FDA, we intend to commercialize this product independently for this indication.
Pluristem plans to retain IP and manufacturing rights in all collaborations at this time.
More about advanced regulatory pathways in Europe and Japan
Pluristem is one of only a handful of companies in the world that have been selected to develop a product using Japan’s rapid regulatory pathway for regenerative medicines. As a result, we have a significant opportunity to bring PLX-PAD more quickly to patients suffering from CLI, a severe, life-threatening condition with poor treatment options.
Our clinical development program in CLI was also selected for the Adaptive Pathways pilot project in Europe. Under this project, the European Medicines Agency is providing us with substantial support and guidance as we prepare a protocol for a randomized, double blind Phase II trial to be submitted for Conditional Marketing Authorization.