Israeli-based drug development company Pluristem Therapeutics has closed enrolment for its Phase II trial of placental expanded (PLX-PAD) cells to treat intermittent claudication (IC), a peripheral artery disease (PAD).
Patient enrolment was conducted at 30 clinical sites in the US, Germany, South Korea, and Israel.
The Phase II trial will be conducted to determine safety and efficacy of PLX-PAD cells compared to placebo to treat IC.
IC is caused due to deposition of fats in the arteries of legs and leads to symptoms such as muscle pain, cramps, numbness or a sense of fatigue, usually in the calf muscle, which occurs during walking or similar exercise.
The firm completed enrolment of 172 people.
Pluristem chairman and CEO Zami Aberman said: “Completion of enrolment for our Phase II IC trial is a major milestone for Pluristem.
"We expect to report top line results in early 2018, which we intend to use to support our future application for a Biologics License Application (BLA) for approval to commercialise PLX - PAD for the treatment of critical limb ischemia (CLI), another peripheral artery disease.
“Now that we have completed the enrolment for this important study, Pluristem is ready to move full steam ahead with the enrolment of the recently announced Phase III trial in CLI. Our immediate goal is to bring PLX products to market as rapidly as possible.”
The European part of the Phase II IC trial principle investigator (PI), and one of the PIs of Pluristem’s upcoming Phase III trial in CLI and the University of Dresden’s Vascular Center at the Technical director professor Norbert Weiss said: “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.”
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.
Phase II IC trial US principal investigator and Duke University Health System cardiology division chief Dr Manesh Patel said: “The option of treating peripheral artery diseases such as 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.”
The prevalence of IC in the US alone is approximately 14 million patients, representing a cost of approximately $2.5bn annually to the national healthcare system.