Data Demonstrating Aeolus Pharmaceuticals’ AEOL 10150’s Efficacy as a Broad Spectrum Countermeasure Against Radiological and Chemical Threats Presented at the GHSI Public Health Emergency Medical Coun

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Aeolus Pharmaceuticals, Inc. AOLS announced today the presentation of data at the GHSI Public Health Emergency Medical Countermeasures Workshop detailing the potential of AEOL 10150 as a broad spectrum medical countermeasure (MCM) to treat radiological and chemical threats. Data presented from studies sponsored by Aeolus, the National Institutes of Health (NIH), National Institutes of Allergies and Immunological Disorders and NIH CounterACT, highlighted AEOL 10150’s efficacy in animal models of Acute Radiation Syndrome (ARS), sulfur mustard gas and chlorine gas exposure.

AEOL 10150 is a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage via signaling cascades induced by radiation or chemical exposure. The compound’s mitigation of organ-specific damage induced by acute exposure to potentially lethal doses of radiation and chemical agents is based on the hypothesis, and supporting data, that these stressors initiate a pro-inflammatory cascade that disrupts organ integrity and function in a radiation or chemical dose- and time-dependent fashion. This common mechanism of action permits analysis of efficacy in multiple models of organ-specific damage. Research is focused on the use of validated animal models and research design compliant with the criteria of the FDA Animal Rule and development of a clear path to licensure by the FDA.

“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 to establish 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.”

In the chemical area, with the guidance and support of NIH CounterACT, Aeolus has conducted studies in collaboration with National Jewish Health, the University of Colorado, McGill University and Lovelace Respiratory Research Institute that have established proof of principle of the compound as a MCM for mustard gas and chlorine gas exposure. Current studies are ongoing in rodents to confirm efficacy and to establish optimal dosing and to expand the treatment window. AEOL 10150’s advantages of dual use (i.e., ARS and cancer radiation therapy) and potential ability to address several threats (i.e., ARS, sulfur mustard gas and chlorine gas) and multiple syndromes within ARS (pulmonary and gastrointestinal) establish its potential to offer an increase in capability compared with currently available countermeasures.

About AEOL 10150

AEOL 10150 is a small molecule that catalytically consumes reactive oxygen and nitrogen species (free radicals). The compound is a manganoporphyrin that contains a positively-charged manganese metal ion that is able to accept and give electrons to and from reactive oxygen species (“ROS”) and reactive nitrogen species (“RNS”). Research has shown that ROS and RNS have important cell signaling roles, and through its interaction with RNS and ROS, AEOL 10150 appears to have multiple mechanisms of action including anti-oxidant, anti-inflammatory and anti-angiogenic activities. In animal studies AEOL 10150 has demonstrated reductions in the markers for tissue hypoxia, angiogenesis, inflammation and oxidative stress. Specifically, AEOL 10150 is able to down-regulate oxidative stress and severe inflammation, which is responsible for much of the tissue destruction that occurs as a result of radiation exposure.

AEOL 10150 offers several unique advantages as a countermeasure for the treatment of ARS, mustard gas and chlorine gas for civilian and military populations. These include:

-- Flexible Treatment Paradigm – AEOL 10150 is intended for the treatment of patients post-exposure, even in those who are already exhibiting symptoms, eliminating the need for immediate administration in a predefined treatment window. This approach has the added benefit of not requiring biodosimetry (a means of laboratory analysis of the blood to determine the level of radiation exposure).

-- Advanced Development Stage – AEOL 10150 has demonstrated safety in three human clinical trials, and has an extensive pre-clinical safety and toxicology package completed. The product also has an established stability profile that permits long-term storage.

-- Large scale manufacturing – Aeolus has contract capacity with a large manufacturing site to mass produce large quantities of AEOL 10150 under GMP conditions.

-- Multiple Applications – AEOL 10150 has demonstrated protective effects against radiation and mustard gas exposure, and within these indications has shown the ability to treat multiple organ systems.

-- Commercial Application – Additionally, AEOL 10150 is being developed for use as an adjunct to cancer radiation therapy, and animal data suggest that the compound protects healthy normal cells from the effects of radiation without compromising the efficacy of the radiation in killing tumor cells.

Potential for AEOL 10150 as a Countermeasure Against Multiple Terrorist Threats

AEOL 10150 has shown significant protective effects against radiation, mustard gas and chlorine gas in animal models. Studies are underway or will shortly be initiated to further explore AEOL 10150’s ability to protect the lungs from damage due to exposure to radiation, mustard gas, and chlorine gas. A compound with the potential to protect against multiple threats would be of significant benefit in both the military and civilian efforts to protect citizens against potential threats. The FDA has a special “Animal Rule” under which compounds may be approved for use against chemical and nuclear threats on the strength of animal efficacy studies, which allows the potential for an accelerated approval path versus conventional pharmaceutical applications.

About Aeolus Pharmaceuticals

Aeolus is developing a variety of therapeutic agents based on its proprietary small molecule catalytic antioxidants, with AEOL 10150 being the first to enter human clinical evaluation. AEOL 10150 is a patented, small molecule catalytic antioxidant that mimics and thereby amplifies the body’s natural enzymatic systems for eliminating reactive oxygen species, or free radicals. Studies funded by the National Institutes for Health are currently underway evaluating AEOL 10150 as a treatment for exposure to radiation, mustard gas and chlorine gas.

The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus’ product candidates, as well as its proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus’ actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities, difficulties or delays in development, testing, obtaining regulatory approval, the need to obtain funding for pre-clinical and clinical trials and operations, the scope and validity of intellectual property protection for Aeolus’ product candidates, proprietary technologies and their uses, and competition from other biopharmaceutical companies. Certain of these factors and others are more fully described in Aeolus’ filings with the Securities and Exchange Commission, including, but not limited to, Aeolus’ Annual Report on Form 10-K for the year ended September 30, 2008. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

Aeolus Pharmaceuticals, Inc.
John L. McManus
President and Chief Executive Officer
1-949-481-9825

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