Aeolus Pharmaceuticals (OTCQB: AOLS)
- Data presented at 6th Annual NIH CounterACT Network
Research Symposium
- AEOL 10150 treatment resulted in 100 percent
survival at 120 hours after exposure compared to 38 percent
survival in control animals
- The improvement in survival correlated with
improvement in skin thickness, reversal of microvesication and
H2A.X phosphorylation
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 and
the University of Colorado have completed studies demonstrating
that AEOL 10150 provides significant skin protection and
significantly improves survival in mice exposed to nitrogen mustard
gas ("NM"). Data were presented at the 6th Annual CounterACT
Countermeasures Against Chemical Threats Network Research Symposium
in Washington, D.C. There are currently no effective treatments for
nitrogen gas exposure to the skin 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. NM has
been stockpiled for potential military use since World War II and
continues to pose a threat to civilian and military personnel. NM
exposure can cause blistering of the skin as well death.
"Treatment with AEOL 10150 by injection and topically of animals
exposed to nitrogen mustard gas resulted in 100 percent survival at
120 hours after exposure compared to 38 percent survival for
untreated animals," 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
results build on the efficacy we have seen with AEOL 10150 against
sulfur mustard gas, chlorine gas and phosgene gas, and demonstrate
the compounds potential as a broad spectrum countermeasure for
chemical threats."
Improves Survival After Nitrogen Mustard
Exposure to the Skin
In the study, 8 animals were assigned per group. The primary
endpoints for the study were reversal of epidermal thickness and
microvesication at 120 hours post-exposure. Treatment with AEOL
10150 after exposure to NM reversed epidermal by 38 percent (p <
0.05) when given subcutaneously, and by 60 percent (p < 0.05)
when given subcutaneously and topically. AEOL 10150 treatment
subcutaneously reduced the incidence of microvesication by 56
percent (medium) and 100 percent (large) compared to control (p
< 0.05). Treatment with AEOL 10150 subcutaneously and topically
reduced the incidence of microvesication by 94 percent (medium) and
100 percent (large) compared to control.
The secondary endpoints for the study were survival and H2A.X
phosphorylation. Survival for animals exposed to NM and treated
with AEOL 10150 subcutaneously was 75 percent, compared to 25
percent in the control group (NM plus PBS). Survival for animals
exposed to NM and treated subcutaneously and topically with AEOL
10150 was 100 percent, compared to 38 percent in the control group
(NM plus PBS and gel). Treatment with AEOL 10150 reversed
NM-induced H2A.X phospohorylation in mouse skin by 34 percent
(subcutaneous only) and by 75 percent (subcutaneous plus
topical).
"AEOL 10150 continues to demonstrate significant efficacy as a
broad spectrum countermeasure against both chemical and
radiological effects, which we believe position it uniquely as a
candidate for use to protect citizens and warfighters," stated John
L. McManus, President and Chief Executive Officer of Aeolus
Pharmaceuticals, Inc. "We are grateful to NIH CounterACT for their
support of this program, and to Dr. Day, Dr. Rajesh Agarwal and Dr.
Carl White for their continuing efforts to find effective
countermeasures for potential chemical threats. With this efficacy
data, we now have 7 indications for which AEOL 10150 has
demonstrated efficacy as countermeasure against chemical and
radiological threats."
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, Rajesh Agarwal, PhD 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 MCM's against sulfur mustard gas exposure.
Potential for AEOL 10150 as a Countermeasure
Against Chemical Threats
AEOL 10150 has shown significant protective effects against
radiation, sulfur mustard gas, nitrogen 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.
National Jewish Health National Jewish
Health is known worldwide for treatment of patients with
respiratory, cardiac, immune and related disorders, and for
groundbreaking medical research. Founded in 1899 as a nonprofit
hospital, National Jewish remains the only facility in the world
dedicated exclusively to these disorders. Since 1998, U.S. News
& World Report has ranked National Jewish the #1 respiratory
hospital in the nation.
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.
Add to Digg Bookmark with del.icio.us Add to Newsvine
Contact: John McManus President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc. 1-(949) 481-9825
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
Historical Stock Chart
From Feb 2025 to Mar 2025
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
Historical Stock Chart
From Mar 2024 to Mar 2025
