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news.Israel-based Pluristem Therapeutics has submitted its application to the US Food and Drug Administration seeking Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells for the treatment of severe preeclampsia.
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Preeclampsia is one of the most common medical complications of pregnancy, and if left untreated it can progress to eclampsia, the life-threatening occurrence of seizures during pregnancy.
It is one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths.
The FDA orphan drug designation would provide benefits including seven year market exclusivity, tax credits as well as guidance on clinical studies.
Pluristem chairman and CEO Zami Aberman said having just recently established the company’s Preeclampsia Steering Committee comprised of key medical opinion leaders, this Orphan Drug application submission is an important step in advancing its preeclampsia development program.
"The tremendous unmet medical need makes this indication one of our top priorities," Aberman said.
"We look forward to advancing into human trials and we are hopeful that the very strong preclinical data for PLX cells will translate into similar results at the clinical level."
The company has already received the FDA orphan drug designation for its PLX cells in two other indications: the treatment of aplastic anemia and the treatment of Buerger’s disease.