Pluristem Therapeutics, Inc. (Nasdaq: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."