Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has obtained US Food and Drug Administration (FDA) clearance to begin a Phase II clinical trial to test the safety and efficacy of its PLX-PAD placental stem cell treatment of intermittent claudication (moderate-severe limping), a subset of peripheral artery disease (PAD), caused by atherosclerosis of the legs.
The clinical trial will include 132 patients at ten locations in the US. The trial will test the safety and efficacy of two dosages of PLX-PAD cells compared with a placebo. The primary endpoint will be the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints will include hemodynamics and quality of life measurements. The trial will also test safety parameters.
Pluristem chairman and CEO Zami Aberman said, "We are excited to receive the world's FDA first clearance for an intermittent claudication clinical trial using allogeneic cell therapy as a potential preventive treatment for this disease. We believe that our approach of repeatable intramuscular injections will potentially enable us to boost the healing process of our patients. In this trial, we will take benefit of our 'off-the-shelf' PLX properties achieved by our 3D proprietary technology platform for efficient, controlled, mass production of cell therapy product candidates, for the treatment of millions of intermittent claudication patients around the world."
Pluristem cites studies which state that intermittent claudication affects 14 million people in the US, costing $2.5 billion in national healthcare costs.
Pluristem's share price rose 8.9% by mid-afternoon on the TASE today to NIS 8.89, after rising 1.6% on Nasdaq yesterday to $2.22, giving a market cap of $98 million. The share price is up 5.9% in premarket trading on Nasdaq today.
Published by Globes [online], Israel business news - http://www.globes-online.com - on April 17, 2012
Copyright of Globes Publisher Itonut (1983) Ltd. 2012
Read more:
FDA approves Pluristem stem cell trial for severe limping