Stem cell company Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today announced it is about to begin Phase II clinical trials in the US to evaluate the safety and efficacy of its PLacental Expanded (PLX) cells in the treatment of Intermittent Claudication (IC), a type of peripheral artery disease (PAD). The US Food and Drug Administration (FDA) granted clearance to start the Phase II clinical trial in April, and Pluristem, which develops placenta-based cell therapies, will commence the trials in the first week of September.
Pluristem has already received Institutional Review Board (IRB) approval for the trial protocol for five out of the eleven US 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 following weeks following. Pluristem also plans to initiate trials in Europe and Israel in parallel to the eleven US sites.
The study's lead principal investigator at Duke Dr. Manesh Patel said, "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 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.
Pluristem chairman and CEO Zami Aberman said, "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."
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. In the US alone there are 14 million IC patients adding $2.5 billion annually to the National Healthcare Bill.
Pluristem's share price rose 2.62% on the TASE today to NIS 16.85, after closing at $4.16 on Nasdaq yesterday, giving a market cap of $186.45 million.
Published by Globes [online], Israel business news - www.globes-online.com - on August 23, 2012
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