Aeolus' AEOL 10150 Significantly Improves Survival From Nitrogen Mustard Exposure to Skin in Animals

MISSION VIEJO, CA--(Marketwired - Jul 2, 2013) - Aeolus Pharmaceuticals (OTCQB: AOLS)

• Data presented at 6^th Annual NIH CounterACT Network Research Symposium
• AEOL 10150 treatment resulted in 100 percent survival at 120 hours after exposure compared to 38 percent survival in control animals
• The improvement in survival correlated with improvement in skin thickness, reversal of microvesication and H2A.X phosphorylation

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against radiological and chemical threats with significant funding from the US Government, announced today that researchers from National Jewish Health and the University of Colorado have completed studies demonstrating that AEOL 10150 provides significant skin protection and significantly improves survival in mice exposed to nitrogen mustard gas ("NM"). Data were presented at the 6^th Annual CounterACT Countermeasures Against Chemical Threats Network Research Symposium in Washington, D.C. There are currently no effective treatments for nitrogen gas exposure to the skin and AEOL 10150 is a major focus of a sponsored research grant awarded by the National Institutes of Health ("NIH") CounterACT program to the University of Colorado and National Jewish Health to identify an effective treatment. NM has been stockpiled for potential military use since World War II and continues to pose a threat to civilian and military personnel. NM exposure can cause blistering of the skin as well death. 

"Treatment with AEOL 10150 by injection and topically of animals exposed to nitrogen mustard gas resulted in 100 percent survival at 120 hours after exposure compared to 38 percent survival for untreated animals," stated Brian Day, PhD, Professor and Vice Chair of Research the Department of Medicine at National Jewish Health and Investigator for the CounterACT Center of Excellence in Denver, and Chief Science Officer of Aeolus Pharmaceuticals, Inc. "These results build on the efficacy we have seen with AEOL 10150 against sulfur mustard gas, chlorine gas and phosgene gas, and demonstrate the compounds potential as a broad spectrum countermeasure for chemical threats." 

Improves Survival After Nitrogen Mustard Exposure to the Skin

In the study, 8 animals were assigned per group. The primary endpoints for the study were reversal of epidermal thickness and microvesication at 120 hours post-exposure. Treatment with AEOL 10150 after exposure to NM reversed epidermal by 38 percent (p < 0.05) when given subcutaneously, and by 60 percent (p < 0.05) when given subcutaneously and topically. AEOL 10150 treatment subcutaneously reduced the incidence of microvesication by 56 percent (medium) and 100 percent (large) compared to control (p < 0.05). Treatment with AEOL 10150 subcutaneously and topically reduced the incidence of microvesication by 94 percent (medium) and 100 percent (large) compared to control.

The secondary endpoints for the study were survival and H2A.X phosphorylation. Survival for animals exposed to NM and treated with AEOL 10150 subcutaneously was 75 percent, compared to 25 percent in the control group (NM plus PBS). Survival for animals exposed to NM and treated subcutaneously and topically with AEOL 10150 was 100 percent, compared to 38 percent in the control group (NM plus PBS and gel). Treatment with AEOL 10150 reversed NM-induced H2A.X phospohorylation in mouse skin by 34 percent (subcutaneous only) and by 75 percent (subcutaneous plus topical).

"AEOL 10150 continues to demonstrate significant efficacy as a broad spectrum countermeasure against both chemical and radiological effects, which we believe position it uniquely as a candidate for use to protect citizens and warfighters," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "We are grateful to NIH CounterACT for their support of this program, and to Dr. Day, Dr. Rajesh Agarwal and Dr. Carl White for their continuing efforts to find effective countermeasures for potential chemical threats. With this efficacy data, we now have 7 indications for which AEOL 10150 has demonstrated efficacy as countermeasure against chemical and radiological threats."

CounterAct Center of Excellence

In 2011, the NIH, through its Countermeasures Against Chemical Threats Research Network (CounterACT) awarded a five-year, $12.7 million grant to Carl White, MD, Rajesh Agarwal, PhD and Brian Day, PhD of the University of Colorado Anschutz Medical Campus and National Jewish Health, both in Denver, Colorado. The grant was awarded to continue the development of AEOL 10150 as a medical countermeasure (MCM) against mustard gas exposure (lung and skin) and chlorine gas exposure (lung). Also included in the grant is support of research looking at tissue plasminogen activator (TPA) and Silabilin as MCM's against sulfur mustard gas exposure. 

Potential for AEOL 10150 as a Countermeasure Against Chemical Threats

AEOL 10150 has shown significant protective effects against radiation, sulfur mustard gas, nitrogen mustard gas, chlorine gas, phosgene gas and nerve agents 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 AEOL 10150
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-signaling cascades resulting from radiation exposure. AEOL 10150 may have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation in the treatment of oncology.

AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event.

About Aeolus Pharmaceuticals
Aeolus Pharmaceuticals is developing a platform of a new class of broad-spectrum, catalytic-antioxidant compounds that protect healthy tissue from the damaging effects of radiation. Its first compound, AEOL 10150, is being developed for oncology indications, where it is used in combination with radiation therapy. It is also being developed, with funding by the US Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons, where its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in oncology. For more information, please visit Aeolus's corporate website at www.aeoluspharma.com.

National Jewish Health
National Jewish Health is known worldwide for treatment of patients with respiratory, cardiac, immune and related disorders, and for groundbreaking medical research. Founded in 1899 as a nonprofit hospital, National Jewish remains the only facility in the world dedicated exclusively to these disorders. Since 1998, U.S. News & World Report has ranked National Jewish the #1 respiratory hospital in the nation.

Forward-Looking Statements

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, the Company's potential initiation of large efficacy studies in mice and NHPs, as well as a phase 1 study in healthy normal volunteers, the BARDA Contract, and the expected use of proceeds from the financing. 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, and whether BARDA exercises one or more additional options under the BARDA Contract. 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, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.