Pluristem Commences U.S. FDA Phase II Clinical Trial for Intermittent Claudication
Duke University Medical Center is 1st of 5 Sites Already Approved
HAIFA, Israel, Aug 23, 2012 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced it will initiate Phase II clinical trials in the United States in the first week of September 2012 to evaluate the safety and efficacy of its PLacental Expanded (PLX) cells in the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). The U.S. Food and Drug Administration (FDA) had granted the Company clearance to start the Phase II clinical trial in April of this year.
Pluristem has already received Institutional Review Board (IRB) approval for the trial protocol for five out of the eleven U.S. clinical site locations via its relationship with Western IRB, which has approved Pluristem's protocol.
Site initiation will begin on September 5th at Duke University Medical Center with other sites becoming active in the weeks following. Pluristem also plans to initiate sites in Europe and Israel in parallel to the eleven U.S. sites.
Dr. Manesh Patel, the study's Lead Principal Investigator at Duke commented, "We are pleased to participate in the clinical trial process of this novel technology. Duke University Medical Center participated as a clinical site in Pluristem's Phase I/II trial using PLX-PAD cells in critical limb ischemia (CLI). We are excited to lead this next phase of trials exploring its potential use for the significant number of patients with peripheral artery disease."
Pluristem's IC Phase II trial will evaluate the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is comprised of approximately 150 patients with IC: Fontaine class IIb, Rutherford category 2-3.
The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed.
"Having worked with Duke University and Dr. Patel in our Phase I/II trial for PLX-PAD in CLI, we expected to have a very efficient process to begin trials and this has certainly been the case. This IC study is part of several trials for the PAD indication including CLI and Buerger's disease, which we are planning to launch as part of our strategy to provide a comprehensive solution to PAD patients around the world," stated Zami Aberman, Chairman and CEO of Pluristem.
About Intermittent Claudication:
IC is a subset of PAD caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, such as aching, cramping, numbness or a sense of fatigue classically in the calf muscle, which occurs during exercise, such as walking and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients and representing a cost of approximately $2.5 billion annually to the National Healthcare Bill (References: The SAGE Group and HCUP 2007 Inpatient Data). |
