Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS)
- Data presented at 7th Annual NIH CounterACT Network
Research Symposium
- AEOL 10150 improved survival up to 82 percent
over 48 hours after exposure
- The improvement in survival correlated with
clinical scores, blood oxygenation and airway obstruction
- Aeolus plans to meet with the FDA and discuss
a pivotal trial design and an acceptable second species for
approval under "the Animal Rule"
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology
company developing compounds to protect against radiological and
chemical threats with significant funding from the US Government,
announced today that researchers from National Jewish Health, the
University of Colorado and the US Army Medical Research Institute
for Chemical Defense ("USAMRICD") have completed third and fourth
studies confirming that AEOL 10150 provides significant lung
protection and significantly improves survival in rats exposed to
whole mustard gas. Data were presented at the 7th Annual CounterACT
Countermeasures Against Chemical Threats Network Research Symposium
in Washington, D.C. There are currently no effective treatments for
mustard gas exposure and AEOL 10150 is a major focus of a sponsored
research grant awarded by the National Institutes of Health ("NIH")
CounterACT program to the University of Colorado and National
Jewish Health to identify an effective treatment. Sulfur mustard
gas has been used in warfare since World War I and continues to
pose a threat to civilian and military personnel. Mustard gas
exposure can cause blistering of the skin as well respiratory
injury, fibrosis and death.
"AEOL 10150 continues to demonstrate significant protective
effects in rescuing the lung against the deleterious effects of
sulfur mustard vapor resulting in major improvements in survival
and lung function," stated Brian Day, PhD, Professor and Vice Chair
of Research the Department of Medicine at National Jewish Health
and Investigator for the CounterACT Center of Excellence in Denver,
and Chief Science Officer of Aeolus Pharmaceuticals, Inc. "These
data affirm our earlier studies where AEOL 10150 protected the lung
against sulfur mustard and the half-mustard, 2-chloroethyl
ethylsufide."
Protects Lungs When Administered After
Exposure Four separate studies using 85 rats and comparing 2
different AEOL 10150 dosing regimens conclusively demonstrated that
AEOL 10150 improves survival against an LD60-70 sulfur mustard gas
exposure. AEOL 10150 improved sulfur mustard gas survival up to 82%
over 48 hours. The improvement in survival seen with AEOL 10150
treated animals after sulfur mustard gas exposure correlated with
improvements in clinical scores, blood oxygenation and airway
obstruction. The best improvements in survival and lung function
occurred with the AEOL 10150 dosing regimen of 5 mg/kg body weight
given every 4 hours by subcutaneous injection (p < 0.0004).
The primary endpoints in these studies were survival and blood
oxygen saturation. Secondary endpoints included clinical scores,
blood gas and histopathology for cast formations. AEOL 10150 or PBS
was given to rats one hour after sulfur mustard vapor exposure and
repeated every 4 or 8 hours. Forty-eight hours after exposure, lung
edema was assessed by changes in the bronchoalveolar lavage (BAL)
protein levels. At euthanasia, 48 hours after exposure, AEOL 10150
significantly improved (p < 0.0001) pulse oximetry, and AEOL
10150 treated rats had improved blood oxygenation throughout the
study period. AEOL 10150 reduced clinical scoring of respiratory
quality and activity by more than 60% at the time of euthanasia (p
< 0.005), and improved clinical scores were seen throughout the
study period. Treatment with AEOL 10150 also restored blood gas
parameters to near normal levels, including: pO2 (p < 0.001),
pCO2 (p < 0.0016) and pH (p < 0.0006). Finally, AEOL 10150
treatment reduced airway cast formation by 50% at 24 hours (p <
0.017).
In prior studies AEOL 10150 reduced lung edema (p < 0.05),
decreased SM-induced increases in macrophages (p < 0.05) and
epithelial cells in BAL fluid (p < 0.05). In all three
measurements AEOL 10150 provided approximately 100 percent
protection -- with levels approximating that of the control animals
in the study. These results indicate that AEOL 10150 significantly
improves survival and attenuates lung injury from mustard gas
exposure and may provide an effective countermeasure against
mustard gas-induced lung injury.
"This study confirms AEOL 10150's potential as an effective
countermeasure for mustard gas exposure. Given the dramatic
improvements in survival and reductions in lung damage that we have
seen in this and former studies, Aeolus plans to meet with the FDA
to discuss the design of a pivotal study in rats, and an
appropriate second species to satisfy the requirements for approval
under the animal rule," stated John L. McManus, President and Chief
Executive Officer of Aeolus Pharmaceuticals, Inc. "We are also
grateful to NIH CounterACT for their support of this program, and
to Dr. Day and Dr. Carl White, who have provided great leadership
to this program."
CounterACT
Center of Excellence In 2011, the NIH,
through its Countermeasures Against Chemical Threats Research
Network (CounterACT) awarded a five-year, $12.7 million grant to
Carl White, MD and Brian Day, PhD of the University of Colorado
Anschutz Medical Campus and National Jewish Health, both in Denver,
Colorado. The grant was awarded to continue the development of AEOL
10150 as a medical countermeasure (MCM) against mustard gas
exposure (lung and skin) and chlorine gas exposure (lung). Also
included in the grant is support of research looking at tissue
plasminogen activator (TPA) and Silabilin as MCMs against sulfur
mustard gas exposure.
Potential for AEOL 10150 as a Countermeasure
Against Chemical Threats AEOL 10150 has shown significant
protective effects against radiation, mustard gas, chlorine gas,
phosgene gas and nerve agents in animal models. 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 United States Food
and Drug Administration (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 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 may 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 performed well in preclinical and non-clinical
studies, demonstrating statistically significant survival efficacy
in an acute radiation-induced lung injury model, and was
well-tolerated in two human clinical trials. 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 platform of a new class of
broad-spectrum, catalytic-antioxidant compounds that protect
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 Department of Health and
Human Services, 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 $118.4 million, to efficiently
develop the compound for use in oncology. For more information,
please visit Aeolus's corporate website at
www.aeoluspharma.com.
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, the
Company's potential initiation of large efficacy studies in mice
and NHPs, as well as a phase 1 study in healthy normal volunteers,
the BARDA Contract, and the expected use of proceeds from the
financing. 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, and
whether BARDA exercises one or more additional options under the
BARDA Contract. 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, 2012. 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: John McManus President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc. 1-(949) 481-9825
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
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