Pluristem Therapeutics Inc , a leading developer of placenta-based cell therapy products, today announced that it has completed enrollment of all 172 patients in a multinational Phase II trial of its PLX-PAD cells in the treatment of intermittent claudication (IC), a peripheral artery disease (PAD).
“PLX-PAD cells are a potentially game-changing, non-invasive and much needed treatment for patients all over the world who suffer from peripheral artery disease. I am looking forward to the results of this IC trial, and to initiation of the Phase III in CLI (PACE study) this year,” commented Prof. Norbert Weiss, MD, Director of the Vascular Center at the Technical University of Dresden, Germany, principle investigator (PI) for the European part of the Phase II IC trial, and one of the PIs of Pluristem’s upcoming Phase III trial in CLI.
“The option of treating peripheral artery diseases like IC and CLI through intramuscular injections of PLX-PAD cells is a promising one and a possible alternative to invasive procedures such as angioplasty or vascular surgery which may not be an option for a substantial portion of patients. Pluristem’s regenerative cell therapy may improve patient care and create economic benefits for the healthcare system,” stated Dr. Manesh Patel, Chief of the Division of Cardiology at Duke University Health System, and the PI for the U.S. part of the Phase II IC trial.
Pluristem’s IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo. Both were administered via intramuscular injections in 172 patients with IC, Fontaine class IIb, Rutherford category 2-3. The primary efficacy endpoint is the change in maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints include hemodynamic and quality of life measurements. Safety parameters are also being assessed.
About Intermittent Claudication
IC is a subset of peripheral artery disease, caused by atherosclerosis of the arteries in the lower extremities. IC is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the national health care system.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They can be used off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Pluristem Therapeutics Inc.
Karine Kleinhaus, MD, MPH
Divisional VP, North America