Pluristem Therapeutics, Inc. (PSTI) said 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). The Phase II trial will be potentially followed by a larger multi-national Phase III study in the U.S., Europe and India.
Last August, the 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.
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