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Aeolus Announces Publication of Data Demonstrating Efficacy of AEOL 10150 in Animal CEES Model of Mustard Gas Skin Exposure

MISSION VIEJO, CA -- (Marketwired) -- 06/18/14 -- Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) today announced the publication of data from animal model studies demonstrating the efficacy of AEOL 10150 when used to treat skin lesions from the sulfur mustard gas analog CEES. The paper, "Catalytic antioxidant AEOL10150 treatment ameliorates sulfur mustard analog 2-chloroethyl ethyl sulfide-associated cutaneous toxic effects," was published in the journal Free Radical Biology and Medicine, Volume 72 (May 2014). The studies were funded by Countermeasures Against Chemical Threats ("CounterACT") Program, the National Institutes of Health Office of the Director, and the National Institute of Environmental Health Sciences. Aeolus is a biotechnology company focused on developing compounds to protect against radiological and chemical threats with significant funding from the US government.

The key findings described in the publication include:

  • Treatment of mice with AEOL 10150 resulted in over 50%(p < 0.05) reversal of CEES-induced skin bi-fold and epidermal thickness, myeloperoxidase activity, and DNA oxidation in mouse skin.
  • Treatment of mouse epidermal JB6 and human HaCaT cells with AEOL 10150 (50 µM) 1 hour post-CEES exposure resulted in significant (p < 0.05) reversal of CEES-induced decreases in both cell viability and DNA synthesis.
  • AEOL 10150 treatment 1 hour after CEES exposure attenuated CEES-induced DNA damage in mouse epidermal JB6 and human HaCaT cells.
  • Cytoplasmic and mitochondrial reactive oxygen species measurements showed that AEOL 10150 treatment drastically ameliorated the CEES-induced oxidative stress in both JB6 and HaCaT cells.

"Our study demonstrates the potential of AEOL 10150 in treating skin lesions caused from exposure to vesicating agents, which can be further optimized and developed as a medical countermeasure against vesicant exposure-related skin effects," stated Rajesh Agarwal, PhD, in the Department of Pharmaceutical Sciences at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences.

"The data published in this paper further supports the testing and optimization of AEOL 10150 in skin injury models with topical nitrogen mustard and sulfur mustard exposure," stated John McManus, Chief Executive Officer of Aeolus. "These studies open up a new potential development pathway for AEOL 10150 in the treatment of skin injury from chemical vesicants. AEOL 10150 continues to demonstrate effectiveness as an MCM against radiological and chemical injury and represents a potential solution to multiple threats. We are grateful to CounterACT for their support of these studies and to Dr. Agarwal and his team for their research efforts."

The development of AEOL 10150 as a treatment for chemical vesicant and nerve gas exposure is funded by the National Institutes of Health's Countermeasures Against Chemical Threats ("CounterACT") program. Aeolus is also developing AEOL 10150 as a treatment for the lung syndrome of Acute Radiation Syndrome ("Lung-ARS") under a five year, cost plus contract with the Biomedical Advanced Research and Development Authority ("BARDA"), a division of the U.S. Department of Health and Human Services. The contract, worth up to $118.4 million, fully funds the development of AEOL 10150 through approval and licensure by the U.S. FDA. Aeolus believes it will be able to meet the requirements for a pre-Emergency Use Authorization application for Lung-ARS by the end of 2014.

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. AEOL 10150 also currently is in development for use as both a therapeutic and prophylactic drug in cancer patients.

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, 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.aeoluspharma.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 NHPs, 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, 2014. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

Contact:

John McManus
President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc.
1-(949) 481-9820

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