Aeolus' AEOL 10150 Supresses Overexpression of 31 Hypoxia-Related Genes Caused by Radiation Exposure
October 17 2012 - 8:55AM
Marketwired
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS)
- AEOL 10150 improves tissue oxygenation and reduces
hypoxia-associated gene expression by more than 99% in the majority
of genes activated after radiation
- Data provide strong biologic rationale to support the observed
improvement in respiratory function and survival in previous
studies
- Mechanism of action is a key element required for FDA approval
under the "Animal Rule"
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology
company leveraging significant government funding to develop a
platform of novel compounds in oncology and biodefense, today
announced the publication of data on AEOL 10150 in the journal,
Free Radical Biology and Medicine. The article, entitled "Temporal
expression of hypoxia-regulated genes is associated with early
changes in redox status in irradiated lung," was authored by Isabel
L. Jackson, PhD, Xiuwu Zhang, MD, PhD, Caroline Hadley, Zahid N.
Rabbani, MD, Yu Zhang, Sam Marks, ZeljkoVujaskovic, MD, PhD.
"The inflammation and scarring of lung tissue that develops
after exposure to high doses of radiation can result in death or a
significant reduction in the quality of life in cancer patients and
victims of radiation accidents or detonations," stated Brian Day,
PhD, Chief Scientific Officer for Aeolus Pharmaceuticals, Inc. "We
have seen AEOL 10150 protect lung tissue from damage and improve
survival in studies conducted in multiple animal species. These new
published findings help explain how AEOL 10150 is protecting lung
tissue and enhancing survival."
Research has demonstrated that AEOL 10150 can significantly
improve lung function and survival after high doses of radiation in
murine and NHP studies. It is now understood that, after radiation
exposure, there is a significant reduction in tissue oxygenation
due to disrupted blood flow, increase in oxygen consumption by
inflammatory cells, and impaired gas exchange in lung tissue
damaged by radiation. The decrease in tissue oxygenation results in
the activation of a number of genes involved in DNA damage/repair
and cell death that can lead to excessive cell loss and oxidative
stress, which can then cause genomic instability, as well as
inflammation, and scar formation. The uncontrolled activation of
these genes results in significant reduction in tissue function
that can lead to life-threatening respiratory impairment. In this
published study, treatment with AEOL 10150 was started 24 hours
after exposure to radiation and continued daily for four weeks.
This treatment regimen resulted in a > 99% reduction in all but
one of the genes activated by radiation exposure, when measured six
weeks post-radiation.
These results suggest that daily treatment with AEOL 10150 for
only four weeks has a sustained effect on the molecular
pathogenesis of radiation damage. This is important since symptoms
of lung damage do not appear for up to 6 months following radiation
exposure. Moreover, these data demonstrate the mechanism by which
AEOL 10150 may confer improved lung function and survival after
acute radiation.
"In addition to showing efficacy in two animal species and
safety in humans, the FDA requires 'a reasonably well-understood
mechanism for the toxicity of the agent and its amelioration or
prevention by the product' for approval under the Animal Rule,"
stated John L. McManus, President and Chief Executive Officer of
Aeolus Pharmaceuticals, Inc. "This study is a critical step forward
in addressing one of the criteria of the FDA Animal Rule for
approval of AEOL 10150. Additional work to further explain AEOL
10150's mechanism of action is being funded under our advanced
research and development contract with BARDA."
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. (949) 481-9825
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
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