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 on the
use of validated animal models and research design compliant 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
Copyright Business Wire 2009
