Preeclampsia is one of the most common medical complications of pregnancy, and a leading cause of premature births, stillbirths and early neonatal and maternal deaths.
Severe preeclampsia occurs in about 1% of pregnancies in Western countries.
In two different studies, PLX-PAD cells improved various parameters of preeclampsia in animal models and demonstrated to be safe for both the mother and fetus.
As part of the FDA’s request, Pluristem is undertaking a study in additional animal model over expression of sFLT-1 to confirm the efficacy of PLX-PAD for testing the efficacy of PLX-PAD in an additional therapeutic pathway. Data is anticipated in the first half of this year.
Pluristem Therapeutics chairman and CEO Zami Aberman said: "Attainment of Orphan Drug Designation for our cells in severe preeclampsia exemplifies our global strategy of bringing cell therapies to patients through accelerated approval pathways.
"We are encouraged by the US FDA designation that demonstrates Pluristem’s commitment to the program and the potential promise it holds to address a serious, unmet medical need faced by pregnant women every year."
Pluristem said occurs after the 20th week of pregnancy and results in high blood pressure and significant amounts of protein in the urine or end-organ dysfunction.
It may result in liver and renal failure, central nervous system abnormalities including seizures, and disseminated intravascular coagulopathy.