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MISSION VIEJO, Calif.(BUSINESS WIRE)
Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) announced today the
presentation of data at the GHSI Public Health Emergency Medical
Countermeasures Workshop detailing the potential of AEOL 10150 as a
broad spectrum medical countermeasure (MCM) to treat radiological and
chemical threats. Data presented from studies sponsored by Aeolus, the
National Institutes of Health (NIH), National Institutes of Allergies
and Immunological Disorders and NIH CounterACT, highlighted AEOL 10150's
efficacy in animal models of Acute Radiation Syndrome (ARS), sulfur
mustard gas and chlorine gas exposure.
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 via signaling cascades induced by radiation
or chemical exposure. The compound's mitigation of organ-specific damage
induced by acute exposure to potentially lethal doses of radiation and
chemical agents is based on the hypothesis, and supporting data, that
these stressors initiate a pro-inflammatory cascade that disrupts organ
integrity and function in a radiation or chemical dose- and
time-dependent fashion. This common mechanism of action permits analysis
of efficacy in multiple models of organ-specific damage. Research is
focused onthe use of validated animal models and research
designcompliant with the criteria of the FDA Animal Rule and
development of a clear path to licensure by the FDA.
To this end we have conducted studies of AEOL 10150 in collaboration
with Duke University, the University of Maryland and a NIAID-sponsored
Research Consortium focused on major organ-specific sub-syndromes of ARS
and delayed effects of acute radiation exposure to establish proof of
principle,? stated John L. McManus, President and Chief Executive
Officer of Aeolus Pharmaceuticals, Inc. Current studies are ongoing in
non-human primates and mice to both confirm efficacy and to establish
optimal dosing and to expand the treatment window.?
In the chemical area, with the guidance and support of NIH CounterACT,
Aeolus has conducted studies in collaboration with National Jewish
Health, the University of Colorado, McGill University and Lovelace
Respiratory Research Institute that have established proof of principle
of the compound as a MCM for mustard gas and chlorine gas exposure.
Current studies are ongoing in rodents to confirm efficacy and to
establish optimal dosing and to expand the treatment window. AEOL
10150's advantages of dual use (i.e., ARS and cancer radiation therapy)
and potential ability to address several threats (i.e., ARS, sulfur
mustard gas and chlorine gas) and multiple syndromes within ARS
(pulmonary and gastrointestinal) establish its potential to offer an
increase in capability compared with currently available countermeasures.
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
three human clinical trials, and has an extensive pre-clinical safety
and toxicology package completed. 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,
mustard gas and chlorine gas in animal models. Studies are underway or
will shortly be initiated to further explore AEOL 10150's ability to
protect the lungs from damage due to exposure to radiation, mustard gas,
and 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. The
FDA has a special Animal Rule? under which compounds may be approved
for use against chemical and nuclear threats on the strength of animal
efficacy studies, which allows the potential for an accelerated approval
path versus conventional pharmaceutical applications.
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 radiation, mustard gas and chlorine gas.
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.
Aeolus Pharmaceuticals, Inc.
John L. McManus
President and
Chief Executive Officer
1-949-481-9825
Source: Aeolus Pharmaceuticals, Inc.
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