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Barda Exercises $3 MM in Additional Contract Funding for Development of AEOL 10150 as Treatment for Acute Radiation Syndrome
Barda Exercises $3 MM in Additional Contract Funding for Development of AEOL 10150 as Treatment for Acute Radiation Syndrome.
About this update from Aeolus Pharmaceuticals Inc
[{"type":"text","content":"\nBarda Exercises $3 MM in Additional Contract Funding for Development of AEOL 10150 as Treatment for Acute Radiation Syndrome\n\nBarda Exercises $3 MM in Additional Contract Funding for Development of AEOL 10150 as Treatment for Acute Radiation Syndrome\n\nMISSION VIEJO, CA--(Marketwired - June 26, 2015) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against radiological and chemical threats in partnership with the US Government, announced today that the Biomedical Advanced Research and Development Authority (BARDA) exercised $3 million in additional contract options under its advanced research and development contract for AEOL 10150. BARDA is a division of the U.S. Department of Health and Human Services that manages the advanced development and purchase of medical countermeasures for public health threats. Aeolus is developing its lead compound, AEOL 10150, as a treatment for the pulmonary syndrome of Acute Radiation Syndrome (Lung-ARS) and delayed effects of acute radiation exposure (DEARE) under a contract with BARDA worth up to $118MM. The contract is designed to produce the data necessary for an approval under the FDA \"Animal Rule\" and for a pre-Emergency Use Authorization (EUA) filing. An approval or pre-EUA would allow the federal government to buy AEOL 10150 for the Strategic National Stockpile under the Pandemic All-Hazards Preparedness Reauthorization Act (PAHPRA). PAHPRA is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile. The options include funding for the following development items:Laboratory work suggested by the FDA as a pathway to removing the clinical hold on the IND for AEOL 10150 in Lung-ARSOngoing animal studies to optimize the administration of AEOL 10150 for Lung-ARS, including duration of treatment and delayed treatment studiesProject management costsOn March 12, 2015, Aeolus met with the Division of Medical Imaging Products at the FDA to discuss the Company's action plan for a complete response to the clinical hold on the IND for AEOL 10150 in Lung-ARS. The discussion at the meeting focused on the path forward to a Phase 1 study in healthy normal volunteers. The FDA asked the Company to perform laboratory studies designed to confirm the non-mutag...