ROCKVILLE, Md.--(BUSINESS WIRE)--MEDIPOST America Inc. (CEO: Dr. Antonio Lee) today announced the US FDA approval of Phase 1/2 clinical trial for PNEUMOSTEM. The Phase 1/2 trial will assess the safety and efficacy of PNEUMOSTEM on prematurely born infants who will be at high-risk of developing Bronchopulmonary Dysplasia (BPD). PNEUMOSTEM is made from allogeneic human Umbilical Cord Blood-derived Mesenchymal Stem Cells (hUCB-MSCs), and is expected to have effect on regenerating the lung tissue and improving inflammatory responses in premature infants. BPD is the leading cause of mortality and severe complications in premature infants and currently no therapy or approved drug exists. Hence, the PNEUMOSTEM trial is expected to draw global attention in the field of neonatal medicine. PNEUMOSTEM received Orphan Drug designation in Korea by the Ministry of Food and Drug Safety (MFDS) and the Phase 2 study in Korea is 80% complete. The US FDA also granted Orphan Drug designation for PNEUMOSTEM, demonstrating its medical value and commercial potential. MEDIPOST America will move quickly to commence the PNEUMOSTEM trial in the U.S. while continuing the licensing and technology transfer negotiations with multinational pharmaceutical companies. The clinical trial approval of PNEUMOSTEM by the US FDA which implements strict regulations on medicinal … Continue reading
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