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Aeolus Pharmaceuticals' AEOL 10150 Protects Lungs Against Chlorine Gas Exposure in Animal Studies

Data Supports Compound's Potential as a Countermeasure for Chlorine Gas Exposure

MISSION VIEJO, Calif.--(BUSINESS WIRE)--Nov 4, 2009 - Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) reported that researchers from National Jewish Health and McGill University have completed a series of preliminary studies demonstrating that AEOL 10150 protects lungs from chlorine gas exposure in mice. There are currently no effective treatments for chlorine gas exposure and AEOL 10150 is a major focus of a sponsored research grant awarded by the NIH CounterAct program to National Jewish Health to identify an effective treatment. Chlorine gas has been used in warfare since World War I and still poses a significant threat to civilian and military personnel, as well as a threat from industrial and transportation accidents. Chlorine gas exposure can cause significant respiratory injury and chemical-induced asthma.

“We are very impressed with the robust effects of AEOL 10150 in rescuing the lung against the deleterious effects of inhaled chlorine gas,” stated Dr. Carl White, pediatric pulmonologist at National Jewish Health and Director of the CounterACT Center of Excellence in Denver. “These data expand our earlier studies where AEOL 10150 protected the lung against mustard gas.”

Protects Lungs When Administered After Exposure

The primary objective of this study was to determine whether administration of AEOL 10150, after exposure, reduces the severity of acute lung injury and asthma-like symptoms induced by chlorine gas. AEOL 10150 was given to mice at a 5 mg/kg subcutaneous dose one hour after chlorine gas exposure (100 ppm for 5 minutes) and repeated every 6 hours. Twenty-four hours after exposure, lung inflammation was assessed by changes in the bronchoalveolar lavage (BAL) cellularity and neutrophil influx. AEOL 10150 significantly reduced (p<0.05, n=6/group) chlorine gas-induced lung inflammation as measured by bronchoalveolar lavage fluid cellularity levels by 40% that appeared to be due to limiting neutrophil influx. AEOL 10150 also significantly attenuated (p<0.05, n=6) the degree of asthma-like airway reactivity induced by chlorine gas exposure by 40%. These results indicate that AEOL 10150 can attenuate lung injury and asthma-like symptoms from chlorine gas exposure and may provide an effective countermeasure against chlorine gas-induced lung injury.

“AEOL 10150 efficacy in the chlorine studies further expand the compounds potential as a broad countermeasure for exposure to multiple terrorist threats, including mustard gas, radiation exposure in the lungs and GI tract and, now, chlorine gas,” stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. “Further NIH-funded studies to confirm the results obtained in this pilot study of chlorine gas are expected to begin shortly.”

CounterAct Center of Excellence

The NIH awarded a five-year, $7.8 million grant to National Jewish Health and the University of Colorado Health Sciences Center, both in Denver, Colorado. “This Center of Excellence was developed to focus on chlorine and sulfur mustard toxicity in the lung and the long-term goal is to develop an effective treatment for chlorine and mustard gas induced injury in the lungs,” stated Dr. White. Members of the Center are establishing optimal compounds, route and mode of delivery and research projects are ongoing to determine countermeasures that will help establish specific interventions needed to treat chlorine and mustard gas-induced injury.

Potential for AEOL 10150 as a Countermeasure Against Chemical Threats

AEOL 10150 has shown significant protective effects against radiation, chlorine and mustard gas in animal models. 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 United States Food and Drug Administration (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 chlorine and mustard gas. Additionally, the Company has plans to initiate animal studies necessary to seek approval of the compound as a treatment to protect the lungs from exposure to radiation.

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.


Contact: Aeolus Pharmaceuticals, Inc.
John L. McManus
President and Chief Executive Officer


Posted: November 2009