BARDA invites Aeolus Pharmaceuticals to submit proposal for development of AEOL 10150

Jan 13 2010

Aeolus Pharmaceuticals, Inc. (OTCBB:AOLS) announced today that after review of the Company’s white paper on development of AEOL-10150 as a countermeasure for the lung effects of acute radiation syndrome, the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Radiological and Nuclear (CBRN) Countermeasures has informed the Company that, after careful analysis and consideration, it has invited Aeolus to submit a full proposal for a contract to develop AEOL 10150 from its current level of technical readiness to FDA approval. The invitation to submit a proposal by BARDA and Aeolus’ proposal are non-binding, and the selection of the Company’s white paper for submission of a full proposal is not a guarantee of a contract, which will be subject to a favorable technical and scientific review and negotiation of fair and reasonable contract terms.

“To this end we have conducted studies of AEOL 10150 in collaboration with Duke University, the University of Maryland and a NIAID-sponsored Research Consortium focused on major organ-specific sub-syndromes of ARS and delayed effects of acute radiation exposure establishing proof of principle”

Aeolus submitted its white paper, “Advanced Development of AEOL 10150 as a Medical Countermeasure for Pulmonary Injury Associated with ARS and DEARE,” to BARDA on August 31, 2009 consistent with the 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 and damage to the lungs (ARS-Lung) and Gastro-intestinal system (ARS-GI).

"We are pleased that to be moving forward to full proposal for AEOL 10150 as a potential countermeasure for BARDA’s lung ARS program, and we believe that the full proposal will allow us to demonstrate to an even greater extent, the growing body of scientific evidence supporting the compound’s potential as a countermeasure for radiation exposure,” stated John L. McManus, President & Chief Executive Officer of Aeolus Pharmaceuticals, Inc. “We are committed to meeting BARDA’s proposal deadline of February 16, 2010, and look forward to their response to our proposal. In the mean time, we anticipate results from our ongoing mice and non-human primate studies, which we hope will add further support to the positive data we have already disclosed for AEOL 10150 as a treatment against radiation exposure.”

“To this end we have conducted studies of AEOL 10150 in collaboration with Duke University, the University of Maryland and a NIAID-sponsored Research Consortium focused on major organ-specific sub-syndromes of ARS and delayed effects of acute radiation exposure establishing proof of principle,” stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. “Current studies are ongoing in non-human primates and mice to both confirm efficacy and to establish optimal dosing and to expand the treatment window.”