Cellular medicinal provider, Mesoblast (ASX:MSB, NASDAQ:MESO) has lodged clinical efficacy and safety data with the US FDA for its lead product candidate, remestemcel-L.
Remestemcel-L, is an investigational therapy comprising stem cells derived from the bone marrow of an unrelated donor which are administered to patients in a series of intravenous infusions.
The clinical submission included a comparative analysis between 309 children who have received remestemcel-L across three separate studies and matched pediatric control patients treated with institutional standard of care.
The company says that the results of the comparative analysis show the effectiveness of remestemcel-L in this patient population, with particular efficacy and survival benefit in patients with the most severe forms of aGVHD - a potentially life-threatening condition which occurs in about 50 per cent of patients who receive an allogeneic bone marrow transplant.
Shares in Mesoblast (ASX:MSB) are trading 2.9 per cent higher at $2.14.