AOLS Aeolus Pharmaceuticals Inc (CE)

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) (PINKSHEETS: AOLS), a biotechnology company that is leveraging up to $140M of government funding in developing a platform of a new class of broad-spectrum catalytic antioxidant compounds as medical countermeasures to radiation exposure to develop them in oncology indications, today announced data from its proof of principle study conducted in a non-human primate model of Pulmonary Acute Radiation Syndrome (ARS) were presented at the 14th International Congress of Radiation Research in Warsaw, Poland.

Key findings in the study include:

1. Exposure of the whole thorax to 11.5 Gy resulted in radiation-induced lung injury in all Non-Human Primates (NHP) in the study and proved 100% fatal in the control animals, despite supportive care including dexamethasone. 11.5 Gy is, therefore, equal to or greater than the LD100/180 dose for the Whole Thorax Lung Irradiation (WTLI) model.

2. AEOL-10150, as administered in this pilot study (daily on d1-28 at 5mg/kg SC), demonstrated potential efficacy as a mitigator against fatal radiation-induced lung injury. Treatment with the drug resulted in 28.6% survival following exposure to a radiation dose that proved to be 100% fatal in the untreated control group.

3. Serial CT scans demonstrated less quantitative radiographic injury (pneumonitis, fibrosis, effusions) in the AEOL-10150 treated cohort suggesting that the drug reduces the severity of the radiographically detectable lung injury.

4. Dexamethasone administration yielded a transient benefit on both clinical and radiographic evidence of pneumonitis. The AEOL-10150 treated cohort required 1/3 less dexamethasone support due to reduced pulmonary injury in the AEOL-10150 treated group, resulting in less frequent clinical "triggers" (respiratory rate ≥ 80) to treat with dexamethasone.

5. The results of this pilot study are encouraging and suggest that treatment with AEOL-10150 results in reduced clinical, radiographic and anatomic evidence of radiation-induced lung injury, which resulted in improved survival. AEOL-10150 merits further study as a post-exposure MCM against radiation-induced lung injury.

AEOL 10150 has now demonstrated a survival advantage in two species of animals exposed to lethal doses of radiation: the mouse and the NHP, which is a requirement for approval by the Food and Drug Administration under its Animal Rule. The Company was awarded a contract valued up to $118 million by the Biomedical Advanced Research and Development Authority (BARDA) for the development of the compound as a medical countermeasure against the effects of radiation exposure on the lungs in February 2011. As part of this contract Aeolus is currently conducting studies to determine the LD30/180, LD50/180, and LD70/180 in both species in the Whole Thorax Lung Irradiation (WTLI) model.

The primary objective of the study was to determine whether post-exposure administration (24 hours) of AEOL 10150 could mitigate radiation-induced lung injury and enhance survival in rhesus macaques exposed to WTLI and administered supportive care. Two cohorts of NHPs (total n=13) were exposed to 11.5Gy LINAC-derived photon radiation in the WTLI protocol. The control cohort had n=6 and AEOL-treated cohort was n=7. This model showed 100% incidence of severe radiation-induced lung damage. AEOL 10150 was administered subcutaneously at 5mg/kg beginning at day 1 post WTLI and continued as a single, daily injection for 28 consecutive days.

The primary endpoint of the study was mortality. Secondary endpoints included respiratory rate (RR), oxygen saturation of peripheral blood (SpO2), and radiographic lung injury as quantified on serial CT scans. The results showed that 2 out of 7 animals in the AEOL 10150 treated group survived, compared to 0 out of 6 animals surviving in the control group. Radiographic analysis demonstrated that, on average, the AEOL 10150 treated animals 28 percent less volume of pneumonitis and fibrosis than the control animals. RR and SpO2 data reflected greater radiation induced lung injury in the control group and correlated with the lung injury and survival data.

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