Pluristem Receives Approval from Indian Ministry of Health for Use of PLX Cells in Phase II Trial for Treatment of Buerger's Disease
Last year U.S. FDA designated Pluristem's PLX cells orphan status for the treatment of Buerger's disease
HAIFA, ISRAEL, August 16, 2012 -- Pluristem Therapeutics, Inc. (NASDAQCM:PSTI; TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that it has received permission from the Indian Ministry of Health to proceed with a Phase II clinical trial for the treatment of thromboangiitis obliterans (Buerger's disease). This Phase II trial will be potentially followed by a larger multi-national Phase III study in the U.S., Europe and India.
Buerger's Disease is highly prevalent in India, affecting approximately 45% to 63% of the patients who have peripheral artery disease (PAD). The prevalence in India is particularly high among smokers. PAD afflicts an estimated 20 million people in India, which translates into approximately 11 million Indians suffering from Buerger's disease. As there are no established treatments available, there is a strong medical need – and therefore a significant market – for the development of therapeutics for this indication.
Last August, the U.S. Food and Drug Administration (FDA) designated Pluristem's PLX cells orphan status for the treatment of Buerger's disease, a severe disease affecting the blood vessels of the extremities. The disease is a recurrent, progressive inflammation and clotting of the small and medium arteries and veins of the hands and feet. Severe pain and ulcers of the extremities may occur, which may lead to amputation.
"We are very excited to begin this Phase II study for the treatment of Buerger's Disease in India," said Zami Aberman, Chairman, President and CEO of Pluristem. "The information gathered in this trial will be a valuable step towards our goal of successfully developing a PLX cell-based product for the treatment of the entire spectrum of peripheral vascular diseases."
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (NASDAQCM: PSTI; TASE: PLTR) is a leading developer of standardized cell therapy products for the treatment of life threatening diseases. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching prior to administration. Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage, when administered locally, and in inflammatory bowel disease, MS and stroke, when administered systemically.
Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.
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