Aeolus Pharmaceuticals' AEOL 10150 Provides Significant Protection of Lungs and Skin in Animal Studies of Mustard Gas ExposureLAGUNA NIGUEL, Calif.--(BUSINESS WIRE)--April 23, 2008 - Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board: AOLS) reported that researchers from National Jewish Research and Medical Center and the University of Colorado have completed a series of studies demonstrating that AEOL 10150 provides statistically significant protection of the lungs and skin in the 2-chloroethyl-ethylsulfide (CEES; half mustard) model of mustard gas exposure in rats. Data were presented at the National Institute of Health's CounterACT Countermeasures Against Chemical Threats Conference in Washington DC. There are currently no effective treatments for mustard gas exposure, and AEOL 10150 is a major focus of a sponsored research grant awarded by the NIH Counteract program to National Jewish to identify an effective treatment.
"We are very impressed with the robust effects of AEOL 10150 in rescuing the lung and skin against the deleterious effects of CEES and are eager to test its efficacy against sulfur mustard vapor," stated Dr. Carl White, pediatric pulmonologist at National Jewish and Director of the CounterACT Center of Excellence in Denver. "It is by far the most promising compound we have tested to date in this acute lung injury model."
Protection of the Lungs
The primary objective of this study was to determine whether administration of AEOL 10150 reduces the severity of acute lung injury induced by mustard gas exposure. AEOL 10150 was given to rats one hour after CEES exposure and again 9 hours later. Eighteen hours after exposure, lung edema and hemorrhage were assessed by changes in the bronchoalveolar lavage protein and red blood cell levels. AEOL 10150 significantly reduced (p less than 0.05) mustard gas-induced lung edema and hemorrhage as measured by bronchoalveolar lavage lactate dehydrogenase activity, protein levels, IgM levels and cellularity. These results indicate that AEOL 10150 rescues the lung from mustard gas exposure and may provide an effective countermeasure against mustard gas-induced lung injury.
Protection of the Skin
The primary objective of this study was to determine whether administration of AEOL 10150 reduces the severity of skin injury induced by mustard gas exposure. AEOL 10150 was given to hairless mice (topically) one hour after CEES exposure and again 9 hours later. Eighteen hours after exposure, skin damage was assessed by changes in skin fold thickness. These results suggest that topical application of AEOL 10150 rescues the skin from CEES-induced skin injury and may provide an effective countermeasure against mustard gas-induced skin injury.
"AEOL 10150 continues to perform well in the mustard studies, and shows promise as a potential treatment for exposure to multiple terrorist threats," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "Further NIH funded studies with whole mustard are expected to begin shortly, and we also plan to initiate animal efficacy studies in protection of the lung from radiation exposure in our effort to satisfy the animal rule requirements for new drug approval in that indication."
Sulfur mustards have been used in warfare since WWI and still pose a significant threat to civilian and military personnel. Mustard gas exposure can cause significant blistering of the skin as well as respiratory injury and fibrosis. Currently there is no antidote for mustard gas exposure and only symptomatic treatment is available.
CounterAct Center of Excellence
The NIH awarded a five-year, $7.8 million grant to National Jewish Medical and Research Center and the University of Colorado Health Sciences Center, both in Denver, Colorado. "This Center of Excellence was developed to focus on sulfur mustard toxicity in the lung and skin and the long-term goal is to develop an effective treatment for mustard gas induced injury in lung and skin," 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 mustard gas-induced injury.
Potential for AEOL 10150 as a Countermeasure Against Chemical Threats
AEOL 10150 has shown significant protective effects against radiation and mustard gas in animal models. Additionally, based on its mechanism, it is believed that the compound may potentially protect against exposure to chlorine gas. Studies have been planned and will shortly be initiated to further explore AEOL 10150's ability to protect the skin and lungs from damage due to exposure to radiation and mustard gas, and the Company is formulating plans with the government to initiate studies in 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 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 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, 2007. 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
Posted: April 2008