Aeolus Pharmaceuticals Submits White Paper to BARDA for Funding of AEOL 10150 as a Countermeasure to Lung Injury Due to Radiation Exposure

Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) announced today that it has submitted a white paper to the Biomedical Advanced Research and Development Authority (BARDA) in response to Special Instructions Amendment 4 to a Broad Agency Announcement (BAA-BARDA-09-34) for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats. The purpose of the special instructions amendment is to specifically solicit solutions for treating cutaneous and/or pulmonary (life-threatening pneumonitis and fibrosis) injuries resulting from exposure to ionizing radiation. BARDA is interested in advanced development and eventual licensure/approval of medical countermeasures for cutaneous and/or pulmonary injuries resulting from an acute exposure to radiation from a radiological/nuclear accident or attack, particularly injuries associated with Acute Radiation Syndrome (ARS) or Delayed Effects of Acute Radiation Exposure (DEARE).

BARDA is seeking safe and effective medical countermeasures that mitigate, treat, affect, delay, or interrupt the progression of cutaneous and/or pulmonary injury caused by ionizing radiation. Aeolus is requesting funding to further develop AEOL 10150 for the treatment and prevention of such pulmonary injuries, including pneumonitis and fibrosis. In animal studies, AEOL 10150 has demonstrated an ability to protect lung tissue against fibrosis, reduce mortality and maintain normal body weights when administered between 2 hours to 24 hours after exposure. Ongoing studies will examine how far beyond the 24-hour window the compound can be administered and still be effective. AEOL 10150 is also being tested by the National Institutes for Health, National Institute for Allergies and Immunological Disorders, Medical Countermeasures Against
Radiological Threats (NIH/NIAID/MCART) as a countermeasure against radiation exposure of the Gastro-intestinal system (ARS-GI).

"We look forward to BARDA's decision regarding our white paper for the advanced development of AEOL 10150. Our compound has demonstrated safety in phase 1 human studies and efficacy in animal studies when administered after radiation exposure, and this potential funding could allow us to complete the development of the compound and file an NDA for approval by the FDA," stated John L. McManus, President & Chief Executive Officer of Aeolus Pharmaceuticals, Inc.

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