Aeolus Announces Presentation of Efficacy Data for AEOL 10150 in Multiple Studies Showing Significant Survival Improvement and Tissue Protection After Radiation Exposure to the Lungs

MISSION VIEJO, CA--(Marketwired - October 20, 2014) -

• Data Reported in Presentation and Posters at the 60th Annual Meeting of the Radiation Research Society

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) today announced that data from its recently completed study in non-human primates (NHP) demonstrating that 60 days of treatment with AEOL 10150 improved survival from 25 percent to 50 percent (p=0.042) - doubling survival at 180 days after radiation exposure to the lungs was presented at the 60^th Annual Meeting of the Radiation Research Society. The data was presented by Ann Farese of the University of Maryland School of Medicine (UM SOM) as part of a presentation on drugs that have shown significant efficacy in animal models of radiation. In addition to the data presented on AEOL 10150, studies completed by UMSOM showing the significant benefit of Neupogen® and Neulasta® in treating the hematopoietic effects of radiation exposure were also presented. Experience with radiation accident victims has shown that patients who are exposed to high levels of radiation and are treated with Neupogen® or Neulasta® and fluids and antibiotics survive the acute effects of radiation, but later die from lung damage or multi-organ failure including the lungs. 

Additionally, two posters on the benefit of treatment with AEOL 10150 in addressing the pulmonary effects of radiation exposure ("Lung ARS") were presented at the meeting. The studies supporting the presentation and publications were funded by the Biomedical Advanced Research and Development Authority ("BARDA") and the National Institute of Allergies and Infectious Diseases, National Institutes of Health.

"Dose Optimization Study of AEOL 10150 in Mitigation of Radiation Induced Lung Injury in CBA/J Mice"

• Treatment with AEOL 10150 for 28 days beginning 24 hours after 14 Gy Whole Thorax Lung Irradiation (WTLI) improved survival from 10 percent to 40 percent (p=0.023)
• Treatment with AEOL 10150 also resulted in a significant improvement (reduction) in pulmonary edema, inflammation and congestion associated with radiation pneumonitis.
• AEOL 10150 treatment also improved lung function and reduced damage to lung tissue.
• Studies were performed by Francis Murgi, PhD, Chiwei Hung, PhD, Lauren Jackson, PhD and Zeljko Vujaskovic, MD, PhD at the University of Maryland, Department of Radiation Oncology, Division of Translational Radiation Sciences

"Using MALDI-MSI to Enable Biomarker Identification and Medical Countermeasure Development for Radiation-Induced Lung Injury"

• MALDI-MS and histology confirmed that AEOL 10150 is present in the lung tissue of animals exposed to WTLI and treated with the drug
• AEOL 10150 reaches the target organ (lung) within 1 ¼ hours of administration
• Changes and abnormal distributions of certain lipids are seen after radiation, but these effects are not seen after treatment with AEOL 10150 after irradiation providing two key potential biomarkers
• Data from the studies further supports AEOL 10150's ability to modulate Pten and positively affect regulation and signaling along the PI3K-AKT-Pten pathway

The data presented at the Radiation Research Society meeting by Ann Farese was conducted by researchers at the University of Maryland School of Medicine (UM SOM) led by Tom MacVittie, PhD, Professor, Division of Translational Radiation Sciences, UM SOM Department of Radiation Oncology. The research builds on 40 years of work that Dr. MacVittie and his team have conducted in the field of radiation research, in which they have helped to define the field of radiation research and have developed efficacy models for radiation damage that focus on the hematopoietic, gastrointestinal and lung sub-syndromes of Acute Radiation Syndrome (ARS) and the Delayed Effects of Acute Radiation Exposure (DEARE). The models developed by his team were published in two issues of the Health Physics Journal, October 2012 and January 2014 and have been presented to the FDA. The FDA has concurred with the hematopoietic and lung models developed by the MacVittie Lab. His team, led by Ann Farese, also conducted the GLP-compliant efficacy studies that led to an FDA advisory committee to recommend approval of Neupogen® as a treatment of the hematopoietic effects of ARS and a $200 million acquisition of this drug by BARDA under Emergency Use Authorization.

Aeolus Pharmaceuticals is developing AEOL 10150 for approval under the FDA Animal Rule (21 CFR 601.90-95) for treatment of Pulmonary Injury Associated with Acute Radiation Exposure ("Lung ARS"). Previous efficacy studies have shown that AEOL 10150 improves survival and reduces lung damage when given 24 hours after exposure to lethal levels of radiation. Lung ARS is a problem for which there is currently no approved treatment. 

"The progress described at the Radiation Research Society meeting in addressing the acute damage and causes of mortality by radiation exposure was very encouraging," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "It also further emphasizes the need for effective treatments to address the delayed effects, such as lung damage. Experience with radiation accident victims shows that leukocyte growth factors, such as Neupogen®, along with fluids and antibiotics have been highly effective in treating acute radiation syndrome out to about 60 days. However, these patients have died from lung damage and multi-organ failure, which highlights the need for treatments for the delayed effects. The data presented on AEOL 10150 demonstrates the tremendous promise our compound shows for treating Lung ARS." 

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 resulting from radiation exposure. The Company believes that AEOL 10150 could have a profound beneficial impact on people who are exposed to high doses of radiation.

AEOL 10150 has already performed well in animal safety studies, was well tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Lung-ARS studies in animals. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating lung ARS, and has will file an IND to allow for human safety testing in patients receiving radiation and chemotherapy for cancer within the next several months. 

About Aeolus Pharmaceuticals

Aeolus Pharmaceuticals is developing 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, with funding from the U.S. Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons. 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 of AEOL 10150 made by U.S. government agencies, 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.aolsrx.com.

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 initiation or potential initiation of large efficacy studies in mice and NHP's as well as a phase 1 study in healthy 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 and 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; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. 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, 2013. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.