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Aeolus Announces Removal of FDA Clinical Hold on AEOL 10150; Initiation of Phase 1 Study in Healthy Volunteers Planned for 2nd Quarter 2016
Aeolus Announces Removal of FDA Clinical Hold on AEOL 10150; Initiation of Phase 1 Study in Healthy Volunteers Planned for 2nd Quarter 2016.
About this update from Aeolus Pharmaceuticals Inc
[{"type":"text","content":"\nAeolus Announces Removal of FDA Clinical Hold on AEOL 10150; Initiation of Phase 1 Study in Healthy Volunteers Planned for 2nd Quarter 2016 \n\nAeolus Announces Removal of FDA Clinical Hold on AEOL 10150; Initiation of Phase 1 Study in Healthy Volunteers Planned for 2nd Quarter 2016\n\n\n MISSION VIEJO, CA--(Marketwired - February 22, 2016) -  Aeolus Pharmaceuticals, Inc.(OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced today 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.\"We thank the FDA for its continued thoughtful review and guidance in the development of 10150 as a medical countermeasure (\"MCM\") for Lung-ARS,\" stated John L. McManus, President and Chief Executive Officer. \"The removal of the clinical hold will allow us to move forward with a Phase 1 safety study in healthy normal volunteers, which we hope to begin in the 2nd quarter. We are also grateful to our development partner, the Biomedical Advanced Research and Development Authority (\"BARDA\") for their continued support and valuable input into our response to the FDA. With the clinical hold removed, we look forward to further advancing the development of 10150 as a MCM for this unmet medical need.\" 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. \n \n About AE...