Pluristem, a leading developer of placenta-based cell therapies for treating local and systemic inflammatory diseases, feels that positive feedback received from both the FDA (Food and Drug Administration) and the EMA (European Medical Agencies) regarding its PLX-PAD product for treating PAD (Peripheral Artery Disease), a chronic disease that progressively restricts blood flow in the limbs, clears the way for further clinical studies with its PLX-PAD cells. The company is now on track to proceed to a Phase II/III trial for CLI (Critical Limb Ischemia) and a Phase II trial for IC (Intermittent Claudication).
The company recently announced the successful completion of a parallel scientific advisory process involving both the U.S. Food and Drug Administration and the European Medical Agencies, in which the FDA and EMA both acknowledged Pluristem’s proposed clinical development plan for PLX-PAD. The goal is to develop an advanced cell therapy product that could help millions of PAD patients.
Pluristem Chairman and CEO, Zami Aberman, commented on the success. “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. What is particularly exciting about this development 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.”
Edwin Horwitz, MD, PhD, President of the International Society for Cell Therapy, and head of Pluristem’s scientific advisory board, added: “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. 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.”
Pluristem’s patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. The cells are grown using the company’s proprietary 3D micro-environmental technology, and offer an off-the-shelf solution that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD is set to target a sub-population of 20 million patients suffering from Peripheral Artery Disease.
For more information visit www.Pluristem.com