Aeolus Files Investigational New Drug Application With US Food and Drug Administration to Enable Initiation of Human Safety Studies for the Development of AEOL 10150 as a Medical Countermeasure Against Lung Damage From Radiation Exposure

MISSION VIEJO, CA--(Marketwired - Aug 20, 2014) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) today announced that it has filed an Investigational New Drug Application (IND) with the Division of Medical Imaging Products of the US Food and Drug Administration (FDA) to enable the initiation of a phase 1 study of AEOL 10150 in healthy human volunteers. The new phase 1 study is designed as the first step in meeting the requirements for approval of the drug as a medical countermeasure for lung damage due to radiation exposure (Lung-ARS) under the FDA's "Animal Rule." Aeolus is developing AEOL 10150 for this indication under a five-year contract with the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $118 million.

AEOL 10150 has previously been tested in 39 patients with Amyotrophic Lateral Sclerosis (ALS) in two phase 1 safety studies where it was well-tolerated with no Serious Adverse Events (SAE) reported. Through work performed under the BARDA contract, the manufacturing process and formulation of AEOL 10150 has been improved and the manufacturing cost has been reduced by approximately 90 percent. Bridging studies comparing the new, improved formulation of AEOL 10150 to the old formulation were recently completed. The old formulation met FDA regulatory/toxicity guidelines for clinical administration in multiple human studies. The new regulatory compliant (GLP) studies demonstrated that the toxicity and pharmacokinetics of the formulations were comparable. These studies also showed that the new formulation is less likely to cause irritation and has superior bioavailability in animals. 

Stability studies with the new formulation have thus far demonstrated stability up to 24 months at room temperature and refrigerated conditions. Stability testing will continue to 60 months. 

Efficacy studies in mice and non-human primates 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 and the damage typically proves to be fatal in humans as well as in non-human primates and rodents. 

"The filing of our IND for Lung-ARS is the culmination of a tremendous effort by our development team, and was made possible by BARDA's investment in our technology and the valuable input and guidance we have received our BARDA Project Coordination Team and from the Medical Imaging Products Division and Office of Counter-Terrorism and Emergency Coordination at the FDA," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "I am grateful for the hard work and commitment of our employees and consultants and for the collaborative partnership we have with BARDA. As a result of our team's efforts and BARDA's investment and valuable input into our program, we are prepared to initiate a human safety study for Lung ARS Medical Countermeasure program once we have FDA clearance, and plan to quickly follow this study, with our first human studies in cancer."

Assuming that the FDA accepts the IND and clinical protocol without restriction and that BARDA exercises the necessary program options, Aeolus plans to initiate a phase 1 study in healthy normal volunteers during the fourth quarter of 2014.

Aeolus currently has an IND in place with the FDA for ALS, and received orphan drug designation for lung damage resulting from Acute Radiation Syndrome (ARS) from the FDA's Office of Orphan Product Development earlier this year. A filing for Fast Track Status is planned before the end of 2014. The Company also plans to file INDs for the development of AEOL 10150 in radiation therapy and for a respiratory disorder within the next 3 to 12 months. 

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 filed an IND to allow for human safety testing of the compound in healthy volunteers. AEOL 10150 is also currently in development for use as both a therapeutic and prophylactic drug in cancer patients.

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 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 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, 2013. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.