Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT) has taken a step toward a Phase IIb clinical trial of stem cell product, and also obtained a $2.5 million grant from the Office of the Chief Scientist to cover R&D costs from March 2010 through February 2011.
Pluristem's share price jumped 15% in premarket trading today from yesterday's close of $1.16, giving a market cap of $21 million.
Pluristem will begin designing two Phase IIb clinical trials for its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (severe obstruction of the arteries) and moderate-severe limping (claudication), after a meeting with the Paul Ehrlich Institute, the German regulatory authority for advanced therapy products.
The Phase I clinical trial on diabetics suffering from critical limb ischemia found that PLX-PAD was safe and even improved their condition. The two Phase IIb studies will further evaluate the safety and efficacy of the drug
Pluristem chairman and CEO Zami Aberman said, “The rapid advancement of PLX-PAD through clinical trials may allow us to bring to the market a cost-effective treatment for critical limb ischemia and moderate-severe claudication as well as to help relieve the large economic burden currently sustained in treating these disorders." He added that the company would use the Chief Scientist grant to accelerate the progress toward the Phase IIb clinical trials.
12 million people in the US suffer from limb ischemia associated with peripheral arterial disease, costing $14.3 billion annually in treatment, plus $10.2 billion a year to treat critical limb ischemia
Published by Globes [online], Israel business news - www.globes-online.com - on June 28, 2010
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