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news.MEDIPOST America, a stem cell biotechnology firm, has received approval from the US Food and Drug Administration (FDA) for a Phase I/II clinical trial designed to evaluate the safety and efficacy of PNEUMOSTEM on prematurely born infants who will be at high-risk of developing Bronchopulmonary Dysplasia (BPD).
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Made from allogeneic human Umbilical Cord Blood-derived Mesenchymal Stem Cells (hUCB-MSCs), PNEUMOSTEM is expected to have effect on regenerating the lung tissue and improving inflammatory responses in premature infants.
Currently, there is no therapy or approved drug for the treatment of BPD, a leading cause of mortality and severe complications in premature infants.
In Korea, the company received orphan drug status for PNEUMOSTEM from the Ministry of Food and Drug Safety (MFDS) and has also completed 80% of the Phase II trial.
PNEUMOSTEM also secured Orphan Drug designation from the FDA in addition to showing its medical value and commercial potential.
Currently, the company is continuing the licensing and technology transfer negotiations with multinational pharmaceutical companies and will initiate the PNEUMOSTEM trial in the US in 2015.
The trial is being carried out with support from the 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.