Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today announced positive three and six-month follow-up results in the two Phase I clinical trials of it placenta-derived cell therapy, PLX-PAD in patents with critical limb ischemia (obstruction of the arteries). The follow-on results indicate that the therapy is safe improves quality of life, and is potentially effective in treating patients and reducing amputations in patients with critical limb ischemia.
Critical limb ischemia is the end stage of peripheral artery disease (PAD), and in manifested in non-healing wounds and gangrene. The trials include 27 patients in Germany and the US. Only one of the 27 patients treated with PLX-PAD required amputation, a 3.7% amputation rate - a 75% reduction in amputation rate compared with historical data, which varies from 20-40%.
Pluristem said that it expects to publish the final results in a peer-reviewed journal within a few months.
Pluristem cited "ACC/AHA Practice Guidelines", which states that chronic critical limb ischemia has a mortality rate of 20% within one year. Half of cases require revascularization to save the limb, and 40% of patients require amputation within six months.
Pluristem chairman and CEO Zami Aberman said that the results of the clinical trials could help millions of patients worldwide. He added that the company was preparing a Phase II trial of PLX-PAD to treat intermittent claudication (muscle pain caused by PAD) and critical limb ischemia.
Pluristem's share price fell 3.6% on Nasdaq yesterday to $2.95, giving a market cap of $121 million, but rose 5.2% on the TASE to NIS 10.95, following the announcement.
Published by Globes [online], Israel business news - www.globes-online.com - on April 13, 2011
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