Aeolus Pharmaceuticals Announces Presentation of AEOL 10150 Data at the HHS 5th Annual Public Health Emergency Medical Countermeasures Enterprise - BARDA Industry Day

MISSION VIEJO, Calif.--(BUSINESS WIRE)--Jan 10, 2011 - Aeolus Pharmaceuticals, Inc. (OTC: AOLS), today announced that it has been invited to deliver an oral presentation on AEOL 10150, the Company's novel, broad-spectrum catalytic antioxidant compound that reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure in development for use in oncology, where it will be used in combination with radiation therapy, and as a medical countermeasure against the pulmonary sub-syndrome of acute radiation syndrome (“Pulmonary Acute Radiation Syndrome” or “Lung-ARS”) as well as the gastrointestinal sub-syndrome of acute radiation syndrome (“GI-ARS”), both caused by exposure to high levels of radiation due to a radiological or nuclear event, at the Biomedical Advanced Research and Development Authority (BARDA) Industry Day.

BARDA resides within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS). The BARDA Industry Day is being held in conjunction with the HHS 5th Annual Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop being held on January 10 through 12, 2011, in Washington, D.C.

The Company's presentation, entitled "AEOL 10150 – A Dual Use, Broad Spectrum Medical Countermeasure Against Radiological and Chemical Threats," includes new data demonstrating that AEOL 10150 protects the lungs and improves survival in both mouse and non-human primate models of Lung ARS, as well as new data showing that the compound also protects and mitigates damage to the lungs in a rat model of chlorine gas exposure. The Company will also be presenting data on the mechanism of damage from radiation exposure to the lungs and AEOL 10150's mechanism of action in mitigating such damage.

Aeolus has submitted proposals to BARDA for development of our compound as a medical countermeasure for Lung-ARS and chlorine gas exposure. The company is awaiting decisions on both proposals. Currently, the chlorine gas program is being funded by the National Institutes of Health (NIH) CounterACT and our GI-ARS program is being funded by NIH-National Institute of Allergy and Infectious Diseases (NIAID).

AEOL 10150 has already performed well in animal safety studies, been well-tolerated in two human clinical trials, demonstrated efficacy in two species in acute radiation syndrome (“ARS”) studies and demonstrated statistically significant survival efficacy in an acute radiation-induced lung injury model. AEOL 10150 has also demonstrated efficacy in validated animal models for GI-ARS, chlorine gas exposure, and sulfur mustard gas exposure. Efficacy has been demonstrated in Lung-ARS in both rodent and non-human primate studies (“NHP”), with AEOL 10150 treated groups showing significantly reduced weight loss, inflammation, oxidative stress, lung damage, and most importantly, mortality. Therapeutic efficacy was demonstrated when delivered after exposure to radiation (24 hours after exposure for mice in the GI-ARS study and NHPs in the Lung-ARS studies, and two hours after exposure for mice in the Lung-ARS studies).

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 could 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 already performed well in animal safety studies, was well-tolerated in two human clinical trials, and has demonstrated statistically significant survival efficacy in an acute radiation-induced lung injury model. AEOL 10150 is also currently in development for use as both a therapeutic and prophylactic drug in cancer patients.

About the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)

PHEMCE is a coordinated interagency effort that is responsible for defining and prioritizing requirements for public health emergency medical countermeasures; focusing research, development, and procurement activities on the identified requirements; and establishing deployment and use strategies for medical countermeasures in the strategic national stockpile. The Stakeholders Workshop includes plenary talks from the U.S. federal government, the American Medical Association, and state and local speakers, as well as seven breakout sessions on various topics related to the PHEMCE mission. The BARDA Industry Day will include a poster session, exhibitor hall and oral presentations highlighting cutting edge medical countermeasure research.

About Aeolus Pharmaceuticals

Aeolus Pharmaceuticals is developing a new class of catalytic antioxidant compounds that protects 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 Government, 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 to efficiently develop the compound for use in oncology. For more information, please visit Aeolus' corporate website at www.aeoluspharma.com.

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, 2009. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

 

Contact: Aeolus Pharmaceuticals, Inc.
Russell Skibsted
Sr. Vice President and Chief Financial Officer
(949) 481-9825

 

Posted: January 2011

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