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 products including stem cell products, is anticipated to boost clinical trial approvals in other European and Asian countries.
MEDIPOST already has experience in U.S. clinical trials with another stem cell product CARTISTEM® for cartilage regeneration in patients with osteoarthritis, which has been market-approved and available in Korea since 2012.
Orphan Drugs treat small number of patients suffering from rare medical conditions with no alternative therapies. Products with Orphan Drug designation can be sold without competition (market exclusivity) for a certain period at relatively high price.
Clinical development of PNEUMOSTEM® is partly supported by Translational Stem Cell & Regenerative Medicine Consortium grant as a part of Public Health and Medicinal Technology R&D Project funded by the Korea Ministry of Health & Welfare and the Korea Health Industry Development Institute.