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Aeolus Pharmaceuticals Inc. (AOLS.OB) Announces AEOL 10150 Diminishes Oxidative Stress and Nerve Damage Following Exposure to Nerve Agent


7/30/2012 9:25:59 AM

MISSION VIEJO, CA--(Marketwire - July 30, 2012) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) (OTCBB: AOLS), a biotechnology company leveraging significant government funding to develop a platform of novel compounds in oncology and biodefense, today announced preliminary results from an ongoing study being conducted by Manisha Patel, PhD at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences to develop AEOL 10150 as a medical countermeasure against nerve agents, entitled "Evaluation of Neuroprotective Effects of AEOL 10150 against Chemical Threat Agents." The study is funded by a Grant from the NIH CounterACT Program.

The primary objectives of the NIH CounterACT Grant awarded to the University of Colorado are to evaluate the neuroprotective efficacy of AEOL 10150 against pilocarpine-induced neurotoxicity in rats. Pilocarpine is a surrogate of nerve agents. Exposure to organophosphate nerve agents, metabolic poisons, or high levels of sulfur mustard and pesticides can trigger seizures and loss of consciousness. The two year award builds on research conducted by Dr. Patel in rodent models of neurotoxicity and neurodegeneration. Her laboratory has demonstrated that oxidative stress plays a central role in seizure-induced brain injury, and since nerve agents elicit seizures, it is important to determine whether AEOL 10150 is neuroprotective against such agents.

The study confirmed AEOL 10150's ability to cross the rat blood brain barrier and achieve sufficient levels to exert its neuroprotective effects. Further, the study showed that subcutaneous administration of AEOL 10150 30 min prior to or 60 and 90 minutes after nerve agent exposure resulted in inhibition of markers of oxidative stress and neuronal damage.

"These new data show that AEOL 10150 has potential neuroprotective properties against chemical nerve agents and broaden the utility of protection proved by AEOL 10150 across the chemical threat spectrum," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "This study builds on prior work that has shown AEOL 10150 to be an effective countermeasure to protect the lungs from damage due to inhalation of chlorine, sulfur mustard, and phosgene gas and well as protection against radiologic damage to the lungs and gastrointestinal tract."

AEOL 10150 is currently under development as a broad spectrum medical countermeasure with support from the US Government. NIH CounterACT is funding research and development of the compound as a countermeasure against exposure to nerve agents, chlorine gas and sulfur mustard gas. NIH-NIAID is conducting animal efficacy studies of the compound as a countermeasure for the Gastro-Intestinal (GI) effects of Acute Radiation Syndrome (ARS), and the Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a contract valued up to $118 million to develop AEOL 10150 as a countermeasure against Lung ARS/Delayed Effects of Radiation Exposure (DEARE).

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 preclinical and non-clinical studies, was well-tolerated in two human clinical trials, and has demonstrated statistically significant survival efficacy in an acute radiation-induced lung injury model. 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 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, including the contract with BARDA valued, with options, at up to $118 million, to efficiently develop the compound for use in oncology.

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. 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' amended Annual Report on Form 10-K/A for the year ended September 30, 2010. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.


Contact:
Russell Skibsted
Sr. Vice President and Chief Financial Officer
Aeolus Pharmaceuticals, Inc.
1-(949) 481-9825

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