Aeolus Pharmaceuticals Announces AEOL 10150 Diminishes Oxidative Stress and Nerve Damage Following Exposure to Nerve Agent
July 30 2012 - 8:48AM
Marketwired
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) (OTCBB: AOLS), a
biotechnology company leveraging significant government funding to
develop a platform of novel compounds in oncology and biodefense,
today announced preliminary results from an ongoing study being
conducted by Manisha Patel, PhD at the University of Colorado
Skaggs School of Pharmacy and Pharmaceutical Sciences to develop
AEOL 10150 as a medical countermeasure against nerve agents,
entitled "Evaluation of Neuroprotective Effects of AEOL 10150
against Chemical Threat Agents." The study is funded by a Grant
from the NIH CounterACT Program.
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. Pilocarpine is a surrogate of nerve agents. Exposure to
organophosphate nerve agents, metabolic poisons, or high levels of
sulfur mustard and pesticides 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.
The study confirmed AEOL 10150's ability to cross the rat blood
brain barrier and achieve sufficient levels to exert its
neuroprotective effects. Further, the study showed that
subcutaneous administration of AEOL 10150 30 min prior to or 60 and
90 minutes after nerve agent exposure resulted in inhibition of
markers of oxidative stress and neuronal damage.
"These new data show that AEOL 10150 has potential
neuroprotective properties against chemical nerve agents and
broaden the utility of protection proved by AEOL 10150 across the
chemical threat spectrum," stated John L. McManus, President and
Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "This study
builds on prior work that has shown AEOL 10150 to be an effective
countermeasure to protect the lungs from damage due to inhalation
of chlorine, sulfur mustard, and phosgene gas and well as
protection against radiologic damage to the lungs and
gastrointestinal tract."
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 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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