MEDIPOST announced that the administration of lung disease stem cell medicine ‘PNEUMOSTEM®’ was completed in 2nd clinical trial on April 15.
Since September 2012, 2nd clinical trial of ‘PNEUMOSTEM®’ was administrated on 70 new born patients in total at Samsung Seoul Hospital and Seoul Asan Hospital, and recently administration was completed on all subjects to the trial.
From now on, MEDIPOST will continue observation on the efficacy of the medicine for 6 months’ period. MEDIPOST is expected to submit clinical test result report to the Korean Ministry of Food and Drug Safety around 1st half of next year, after subsequent verification of clinical data and analysis works etc.
In this regard, MEDIPOST explained that “We are going to request designation of this medicine as Orphan Drug to Korean Ministry of Food and Drug Safety after completed analysis on the result of 2nd clinical trial this time. Thereafter, accelerated approval process will be pursued according to relevant regulation.”