Pluristem advances towards multinational Phase III trial of PLX-PAD

Pluristem Therapeutics Inc. (PSTI), a leading developer of placenta-based cell therapy products, today announced it intends to conduct a Phase III trial assessing its PLX-PAD cells in recovery following surgery for femoral neck fracture, which is the most common form of hip fracture.

The trial protocol is now being designed by Pluristem and its Clinical Advisory Board (CAB), which is comprised of world-leading orthopedic surgeons, and experts in rehabilitation. Pluristem is planning to meet with the FDA later this year to discuss the Phase III protocol. The Company has already submitted this protocol to the European Medicines Agency (EMA) following consultation with the Adaptive Pathways Project Group. Pluristem’s program in critical limb ischemia is already being developed via the Adaptive Pathways Project.

The trial protocol is now being designed by Pluristem and its Clinical Advisory Board (CAB), which is comprised of world-leading orthopedic surgeons, and experts in rehabilitation. Pluristem is planning to meet with the FDA later this year to discuss the Phase III protocol. The Company has already submitted this protocol to the European Medicines Agency (EMA) following consultation with the Adaptive Pathways Project Group. Pluristem’s program in critical limb ischemia is already being developed via the Adaptive Pathways Project.

The Phase III study design builds upon positive data from a Phase II trial which showed that PLX-PAD cells induced significant muscle regeneration in patients who had undergone total hip replacement surgery. Patients treated with PLX-PAD at the time of surgery showed a 500% improvement in muscle force and a 300% improvement in muscle volume six months after surgery, as compared to the placebo group.

Muscle injury related to surgery, or to immobilization following surgery, may impact effective rehabilitation, and can lead to the loss of the ability to live independently, severe morbidity, and increased mortality. In the U.S., according to different sources, the lifetime prevalence of a hip fracture is 20% for women and 10% for men. Annual treatment costs in the U.S. are estimated to be between $10 to $15 billion, and are expected to rise because of the aging population.

“PLX-PAD’s proven ability to regenerate muscles could play a critical role in improving the outcomes of the growing number of surgeries for femoral neck fracture,” stated Pluristem Chairman and CEO Zami Aberman. “We are eager to move into Phase III trial in the U.S. and Europe in this important orthopedic indication. We look forward to working with the FDA and EMA to receive clearance to commence the trials.”

Experts present at the meeting:

• Dr. Tobias Winkler. Charité – Universitätsmedizin Berlin, Germany
• Prof. Mohit Bhandari – McMaster University, Hamilton, Canada
• Dr. Kenneth Koval –  Orlando Health Orthopedic Institute
• Prof. Laurie Burke –  LORA Group, Maryland
• Prof. Jack Guralnik –  University of Maryland 
• Prof. Jay Magaziner – University of Maryland 
• Prof. Thomas Einhorn – New York University

About Hip Fracture

Fractures of the hip are relatively common in adults and are associated with substantial morbidity and mortality. Most hip fractures occur in elderly individuals as a result of minimal trauma, such as a fall from the standing position.  One-year mortality rates have been reported to range from 12 to 37 percent, and approximately half of patients are unable to regain their ability to live independently. In 2003, there were 310,000 individuals hospitalized with hip fractures in the U.S., according to data from the United States Agency for Healthcare Research and Quality (AHRQ), accounting for 30 percent of all hospitalized patients. As the U.S. population ages, the annual number of hip fractures is expected to increase significantly. The estimated cost for treatment of hip fracture is approximately $10 to $15 billion per year in the United States.