Aeolus Pharmaceuticals Announces NIH Counteract Grant Award to Develop AEOL 10150 as a Treatment Against Nerve Agent Exposure
October 24 2011 - 7:01AM
Marketwired
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) (PINKSHEETS: AOLS), a
biotechnology company leveraging significant funding from the U.S.
Department of Health and Human Services to develop a novel platform
of compounds to treat radiation and chemical exposure, as well as
oncology indications, today announced that NIH CounterACT has
awarded a $735,951 contract to Manisha Patel, PhD at the University
of Colorado Anschutz Medical Campus to develop AEOL 10150 as a
medical countermeasure (MCM) against nerve agents, titled
"Evaluation of Neuroprotective Effects of AEOL 10150 against
Chemical Threat Agents."
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. Exposure to nerve agents, metabolic poisons, or high levels
of sulfur mustard 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.
"We are pleased to see the expansion of the research and
development of AEOL 10150 as a broad spectrum medical
countermeasure, and are grateful for the support that NIH
CounterACT provides for the development of this promising compound.
With this project, the US Government is now funding research and
testing of AEOL 10150 in five MCM indications," stated John L.
McManus, President and Chief Executive Officer of Aeolus
Pharmaceuticals, Inc. "Aeolus appreciates our partnership with the
University of Colorado and the excellent research that Dr. Patel
has done to be awarded this grant, and looks forward to the results
of her research."
The new studies will build on prior work that has shown AEOL
10150 to be an effective countermeasure to protect the lungs from
damage due to inhalation of chlorine gas and sulfur mustard
gas.
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 Nerve Agents The elicitation of
seizures is a common manifestation of nerve agents that target the
central nervous system. Therefore it is important for medical
countermeasures to intervene at two levels. The first level of
intervention is usually to ameliorate the symptoms arising due to
the specific interaction of the agent and cellular targets. Nerve
agents and organophosphate pesticides bind and inhibit
acetylcholinesterase leading to a persistent increase cholinergic
tone. This produces acute effects of nerve agent poisoning
including muscle paralysis, cardiorespiratory depression, massive
secretion from mucous membranes, eye irritation, and blurry or dim
vision which can be controlled by atropine and other cholinergic
antagonists. A second level of intervention is targeting the
delayed injury response to the threat agents. Seizure activity is
the most critical injury response common to nerve agents and
organophosphate exposures. Oxidative stress is a consequence of
chemical convulsants. An important by-product of mitochondrial
metabolism, xenobiotic detoxification and other enzymatic chain
reactions is the production of reactive oxygen species (ROS).
Excessive production of ROS can overwhelm antioxidant defenses
resulting in oxidation of vulnerable cellular targets. Work from
Dr. Patel's laboratory has demonstrated that seizures resulting
from chemical convulsants such as pilocarpine and kainic acid
oxidatively damage mitochondrial DNA, susceptible mitochondrial
proteins and cellular lipids. This pilot project can rapidly
identify AEOL 10150 as a neuroprotectant against nerve agents and
expand its use as a potential medical countermeasure.
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.
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Contact: Russell Skibsted Sr. Vice President and Chief Financial
Officer Aeolus Pharmaceuticals, Inc. 1-(949) 481-9825
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
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