Post by Deleted on Jan 10, 2019 0:59:56 GMT
Pluristem Therapeutics Inc. (Nasdaq: PSTI), a leading regenerative-medicine company developing novel placenta-based cell therapy products, today reported a successful one-year follow up of a compassionate use treatment in a Buergerâs disease patient treated with Pluristemâs PLX-PAD.
The thirty-six years old patient, who was diagnosed with Buergerâs disease approximately four years ago, displayed painful, non-healing ulcers on his foot. Available medical interventions, including revascularization procedures, were unsuccessful in restoring sufficient blood flow to the affected limb and the patient progressed to a pre-amputation stage. Following his physicianâs request and regulatory approval, patient was given a compassionate use treatment of PLX-PAD cells, consisting of two administration to the foot and calf, approximately eight weeks apart.
âThe patient was in an advanced stage of Buergerâs disease and was facing amputation,â said Prof Boris Yoffe, Department of General and Vascular Surgery at the Barzilai Medical Center in Israel. âFollowing treatment with PLX-PAD cells, we observed demonstrable restoration of the patientâs peripheral blood supply to the injured limb, which was manifested by a significant improvement in color, warmth, wound size and reduced pain. One year following treatment, the wound is now fully closed, the patient was able to resume normal activities and amputation was prevented. This treatment highlights PLX-PADâs ability to reduce inflammation, stimulate growth of new blood vessels and support treatment in ischemic conditions such as Buergerâs disease and Peripheral Arterial Diseases (PAD). Additionally, the other limb, which was in earlier stages of the disease, also showed signs of improvement demonstrating the cellsâ ability to prevent progression of the disease and act as a potential systemic treatment. I am highly encouraged by these results providing hope for Buergerâs disease patients and am happy to see the significant improvement in the patientâs medical condition, quality of life and overall wellbeing.â
âThe positive outcome experienced by the patient reflects what we believe is the broad potential of PLX-PAD in treating a wide range of vascular and inflammatory conditions, where improved treatment paradigms are surely needed,â said Zami Aberman, Chairman & Co-CEO of Pluristem. âWhile we advance PLX-PAD in our ongoing multinational Phase III clinical study in critical limb ischemia (CLI), we are pleased to see more supportive evidence of patients benefiting from our PLX regenerative agents. We are now enabling access to PLX-PAD treatment through our U.S. Expanded Access Program in CLI and will explore to expand the program to include Buergerâs disease patients.â
Buergerâs disease (thromboangiitis obliterans) is a recurring progressive inflammatory disease resulting in clotting of small and medium size arteries and veins of the hands and feet. The specific cause of Buergerâs disease remains unknown. The risk for developing Buergerâs disease increases with heavy smoking. There is no cure available today for Buergerâs disease. The initial symptoms of Buergerâs disease often begin with claudication, progressing to pain at rest. If the condition is severe, complications like gangrene may accrue which may lead to limb amputation.
PLX-PAD has been granted Orphan Drug Designation by the FDA for the treatment of Buergerâs disease.
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The thirty-six years old patient, who was diagnosed with Buergerâs disease approximately four years ago, displayed painful, non-healing ulcers on his foot. Available medical interventions, including revascularization procedures, were unsuccessful in restoring sufficient blood flow to the affected limb and the patient progressed to a pre-amputation stage. Following his physicianâs request and regulatory approval, patient was given a compassionate use treatment of PLX-PAD cells, consisting of two administration to the foot and calf, approximately eight weeks apart.
âThe patient was in an advanced stage of Buergerâs disease and was facing amputation,â said Prof Boris Yoffe, Department of General and Vascular Surgery at the Barzilai Medical Center in Israel. âFollowing treatment with PLX-PAD cells, we observed demonstrable restoration of the patientâs peripheral blood supply to the injured limb, which was manifested by a significant improvement in color, warmth, wound size and reduced pain. One year following treatment, the wound is now fully closed, the patient was able to resume normal activities and amputation was prevented. This treatment highlights PLX-PADâs ability to reduce inflammation, stimulate growth of new blood vessels and support treatment in ischemic conditions such as Buergerâs disease and Peripheral Arterial Diseases (PAD). Additionally, the other limb, which was in earlier stages of the disease, also showed signs of improvement demonstrating the cellsâ ability to prevent progression of the disease and act as a potential systemic treatment. I am highly encouraged by these results providing hope for Buergerâs disease patients and am happy to see the significant improvement in the patientâs medical condition, quality of life and overall wellbeing.â
âThe positive outcome experienced by the patient reflects what we believe is the broad potential of PLX-PAD in treating a wide range of vascular and inflammatory conditions, where improved treatment paradigms are surely needed,â said Zami Aberman, Chairman & Co-CEO of Pluristem. âWhile we advance PLX-PAD in our ongoing multinational Phase III clinical study in critical limb ischemia (CLI), we are pleased to see more supportive evidence of patients benefiting from our PLX regenerative agents. We are now enabling access to PLX-PAD treatment through our U.S. Expanded Access Program in CLI and will explore to expand the program to include Buergerâs disease patients.â
Buergerâs disease (thromboangiitis obliterans) is a recurring progressive inflammatory disease resulting in clotting of small and medium size arteries and veins of the hands and feet. The specific cause of Buergerâs disease remains unknown. The risk for developing Buergerâs disease increases with heavy smoking. There is no cure available today for Buergerâs disease. The initial symptoms of Buergerâs disease often begin with claudication, progressing to pain at rest. If the condition is severe, complications like gangrene may accrue which may lead to limb amputation.
PLX-PAD has been granted Orphan Drug Designation by the FDA for the treatment of Buergerâs disease.
www.streetinsider.com/dr/news.php?id=14991121
C L