Aeolus Pharmaceuticals Initiates Second Study of AEOL 10150 as a Countermeasure to Radiation Exposure in Mice

Aeolus Pharmaceuticals Initiates Second Study of AEOL 10150 as a Countermeasure to Radiation Exposure in Mice

MISSION VIEJO, Calif.--(Business Wire)--
Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board: AOLS) announced today the
initiation of a second study, in mice, to determine the optimal length of
treatment with AEOL 10150 when used as a countermeasure to Acute Radiation
Syndrome (ARS) in the lungs. This study, led by Zeljko Vujaskovic, M.D. Ph.D. of
Duke University, is designed to build on the recently completed study that
demonstrated the efficacy of AEOL 10150 as a treatment for damage to the lungs
due to exposure to radiation, and determine the most effective duration of
delivery for treatment after exposure.

AEOL 10150 has been shown to be safe and well tolerated in two phase 1 safety
studies, and in animal studies it has been proven to be efficacious in
protecting the lungs from radiation damage and increasing survival at doses in
the range of 5 to 30 mg/kg given daily up to 24 hrs after irradiation and
administered for as long as 10 weeks. The compound mitigated functional lung
injury in rats and led to a statistically significant survival advantage in
mice. In rodents and humans, radiation of the lungs can cause reduced breathing
capacity, pneumonitis, fibrosis, weight loss and death and is characterized by
oxidative stress, inflammation and elevated macrophage counts. AEOL 10150 has
proven to be an effective countermeasure to radiation exposure of the lungs in
mice and rats.

"This study will provide important insight into the most appropriate length of
treatment with AEOL 10150 to protect the lungs following exposure to radiation,"
stated John L. McManus, President and Chief Executive Officer of Aeolus
Pharmaceuticals, Inc. "The results of this study will be critical in helping us
design the pivotal study in mice, which we expect will be one of the two species
necessary for approval of AEOL 10150 as a countermeasure to nuclear threats
under the US FDA`s Animal Rule."

About AEOL 10150

AEOL 10150 is a small molecule that catalytically consumes reactive oxygen and
nitrogen species (free radicals). The compound is a manganoporphyrin that
contains a positively-charged manganese metal ion that is able to accept and
give electrons to and from reactive oxygen species ("ROS") and reactive nitrogen
species ("RNS"). Research has shown that ROS and RNS have important cell
signaling roles, and through its interaction with RNS and ROS, AEOL 10150
appears to have multiple mechanisms of action including anti-oxidant,
anti-inflammatory and anti-angiogenic activities. In animal studies AEOL 10150
has demonstrated reductions in the markers for tissue hypoxia, angiogenesis,
inflammation and oxidative stress. Specifically, AEOL 10150 is able to
down-regulate oxidative stress and severe inflammation, which is responsible for
much of the tissue destruction that occurs as a result of radiation exposure.

AEOL 10150 offers several unique advantages as a countermeasure for the
treatment of ARS, mustard gas and chlorine gas for civilian and military
populations. These include:

-- Flexible Treatment Paradigm - AEOL 10150 is intended for the treatment of
patients post-exposure, even in those who are already exhibiting symptoms,
eliminating the need for immediate administration in a predefined treatment
window. This approach has the added benefit of not requiring biodosimetry (a
means of laboratory analysis of the blood to determine the level of radiation
exposure).

-- Advanced Development Stage - AEOL 10150 has demonstrated safety in two human
clinical trials, and has an extensive pre-clinical safety and toxicology package
completed.

-- Safe and Easily Stored -- The product also has an established stability
profile that permits long-term storage.

-- Large scale manufacturing - Aeolus has contract capacity with a large
manufacturing site to mass produce large quantities of AEOL 10150 under GMP
conditions.

-- Multiple Applications - AEOL 10150 has demonstrated protective effects
against radiation and mustard gas exposure, and within these indications has
shown the ability to treat multiple organ systems.

-- Commercial Application - Additionally, AEOL 10150 is being developed for use
as an adjunct to cancer radiation therapy, and animal data suggest that the
compound protects healthy normal cells from the effects of radiation without
compromising the efficacy of the radiation in killing tumor cells.

Potential for AEOL 10150 as a Countermeasure Against Multiple Terrorist Threats

AEOL 10150 has shown significant protective effects against radiation and
mustard gas in animal models. Additionally, based on its mechanism, it is
believed that the compound may potentially protect against exposure to chlorine
gas. Studies will shortly be initiated to further explore AEOL 10150`s ability
to protect the skin and lungs from damage due to exposure to mustard gas, and to
protect the lungs from exposure to chlorine gas. A compound with the potential
to protect against multiple threats would be of significant benefit in both the
military and civilian efforts to protect citizens against potential threats.

About Aeolus Pharmaceuticals

Aeolus is developing a variety of therapeutic agents based on its proprietary
small molecule catalytic antioxidants, with AEOL 10150 being the first to enter
human clinical evaluation. AEOL 10150 is a patented, small molecule catalytic
antioxidant that mimics and thereby amplifies the body`s natural enzymatic
systems for eliminating reactive oxygen species, or free radicals. Studies
funded by the National Institutes for Health are currently underway evaluating
AEOL 10150 as a treatment for exposure to mustard gas and will shortly be
initiated to evaluate the compound as a treatment for exposure to chlorine gas.
Additionally, the Company has initiated animal studies necessary to seek
approval of the compound as a treatment to protect the lungs from exposure to
radiation.

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,
2008. Readers are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof.

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