Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths. The only definitive treatment is abortion or delivery. It is estimated that preeclampsia costs the global health care system $3 billion annually. Severe preeclampsia occurs in approximately 1% of pregnancies in the developed world. Due to the high risk of severe complications and mortality for the mother and baby, women diagnosed with severe preeclampsia are generally delivered soon after diagnosis, even if the baby will be born very prematurely. However, when remote from term, delivery is associated with an increased risk of perinatal complications (high neonatal mortality, respiratory distress syndrome, prolonged hospital stay in neonatal intensive care units, and long-term disability in surviving infants). Severe pre-eclampsia remains a major unmet medical need and new innovative treatments with the potential to safely prolong pregnancy are needed.
The U.S. Food and Drug Administration (FDA) has granted our PLX-PAD cells an Orphan Drug Designation for the treatment of severe preeclampsia, and we are completing the preclinical trials requested by the FDA to support an application to conduct a Phase I clinical trial in that indication.