Aeolus Pharmaceutical inc. announced that it has received notice that the U.S. Food & Drug Administration ("FDA") has removed the clinical hold on the Company's Investigational New Drug application for AEOL 10150 ("10150") as a treatment for the lung and delayed effects of acute radiation exposure ("Lung-ARS"). The lifting of the clinical hold allows the Company to initiate its planned human safety study in healthy normal volunteers.
10150 is being developed as a MCM for Lung-ARS under a contract valued at up to $118.4 million with the BARDA, a division of the U.S. Department of Health and Human Services. In multiple studies, 10150 has demonstrated both survival advantage and protection of healthy lung function in animals subjected to lethal doses of acute radiation. There are no current treatments for Lung-ARS.
10150 has been awarded Orphan Drug status by the Office of Orphan Products Development of the FDA for Lung ARS. The Company intends to file a pre-Emergency Use Authorization application with the FDA for the use of 10150 in Lung-ARS upon the completion of the planned safety program.
