Aeolus Pharmaceuticals, Inc. (OTC: AOLS), a biopharmaceutical
company developing a new class of broad spectrum catalytic
antioxidant compounds that reduce oxidative stress, inflammation,
and subsequent tissue damage-signaling cascades resulting from
radiation exposure, today announced that the Biomedical Advanced
Research and Development Authority (BARDA), part of the Department
of Health and Human Services (HHS), has awarded Aeolus a contract
for the advanced development of AEOL 10150 as a medical
countermeasure (MCM) against the pulmonary sub-syndrome of acute
radiation syndrome (ARS).
Under terms of this cost plus, fixed fee development contract,
Aeolus will receive $10.4 million in the first year base period of
performance and up to an additional $107.5 million in options , if
exercised by BARDA, for a total contract value of up to $118
million. In addition to fully covering the cost of development of
AEOL 10150 as an MCM for Lung ARS, the Company believes that the
contract with BARDA will substantially cover all of the costs
associated with the preclinical, chemistry, manufacturing, and
controls (CMC) and toxicology necessary for the oncology
indications, plus a large safety study in humans. A procurement of
AEOL 10150 for the Strategic National Stockpile could occur after
approval from the U.S. Food and Drug Administration, if obtained,
or sooner under an Emergency Use Authorization (EUA). Under the
Company’s development plan, documents for submission of an EUA
would be prepared and submitted to the government in approximately
2 ½ years. The value of a procurement, if any, is not included in
the contract value announced herein.
“We are excited to have the support of BARDA for this important
program and look forward to a highly productive relationship to
develop an effective countermeasure to the pulmonary effects of
ARS,” said John L. McManus, Chief Executive Officer and President
of Aeolus Pharmaceuticals, Inc. “This contract will allow us to
accelerate the development of 10150 as a medical countermeasure,
and it will also, importantly, allow us to expand its development
for use in oncology indications, where it would be used in
combination with radiation therapy. We believe that the dual-use,
broad-spectrum characteristics of AEOL 10150 make it a very unique
and exciting compound with excellent potential.”
AEOL 10150 is currently also being studied by the National
Institutes of Health’s (NIH) National Institute of Allergy and
Infectious Diseases (NIAID) Radiation/Nuclear Medical
Countermeasures development program as a countermeasure for
radiation exposure to the gastrointestinal tract and by NIH
CounterACT as countermeasure against chlorine gas and sulfur
mustard gas exposure.
Aeolus is pleased to partner with HHS-BARDA, the University of
Maryland, Duke University, Johnson Matthey Pharma Services, Albany
Molecular Research and Symbion Research International in this
comprehensive development program. Development of AEOL 10150 to
submission of a New Drug Application (NDA) in the indication of the
pulmonary sub-syndrome of ARS is expected to take approximately
five years.
The Company plans to initiate a Phase I study of AEOL 10150 in
oncology in the 1st half of 2011.
About Acute Radiation Syndromes (ARS)
Immediately after exposure, the most critical components of
acute radiation syndrome are the hematopoietic (bone marrow) and
early-onset gastrointestinal (GI) syndromes because symptoms begin
very quickly and can be lethal. However, depending on the level and
location of radiation exposure, much of the lethality of both
hematopoietic and early-onset gastrointestinal syndromes are
potentially avoidable with proper treatment, including supportive
care (fluids and antibiotics) and Neupogen, leaving complications
to later responding tissues subsequently becoming a major
problem.
In situations of accidental exposure, it was initially assumed
that a whole-body dose exceeding 10 Gy was inevitably fatal.
However, experience with nuclear accident victims suggests that
when patients survive gastrointestinal and bone marrow syndromes,
respiratory failure become the major cause of death. This effect is
known as a delayed effect of acute radiation exposure (DEARE).
About Cancer Radiation Therapy
According to the American Cancer Society, cancer is the second
leading cause of death by disease representing one out of every
four deaths in the United States. According to the Radiological
Society of North America, about 50 to 60 percent of cancer patients
are treated with radiation at some time during their disease. The
NIH estimates overall costs of cancer in 2008 in the United States
at $228.1 billion: $93.2 billion for direct medical costs, $18.8
billion for indirect morbidity costs (costs of lost productivity
due to illness) and $116.1 billion for indirect mortality costs
(cost of lost productivity due to premature death).
About BARDA
The Biomedical Advanced Research and Development Authority
(BARDA), within the Office of the Assistant Secretary for
Preparedness and Response in the U.S. Department of Health and
Human Services, provides an integrated, systematic approach to the
development and purchase of the necessary vaccines, drugs,
therapies, and diagnostic tools for public health medical
emergencies. BARDA was established to provide funding and
coordination to address challenges in medical countermeasure
development. BARDA was created to increase funding for advanced
research and development and to better coordinate the U.S.
government’s medical countermeasure development and acquisition
process. BARDA manages Project BioShield, which includes the
procurement and advanced development of medical
countermeasures for chemical, biological, radiological, and nuclear
agents, as well as the advanced development and procurement of
medical countermeasures for pandemic influenza and other emerging
infectious diseases that fall outside the scope of Project
BioShield.
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. The Company believes
that 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 animal safety studies,
was well-tolerated in two human clinical trials, and has
demonstrated statistically significant survival efficacy in an
acute radiation-induced lung injury model. AEOL 10150 is also
currently in development for use as both a therapeutic and
prophylactic drug in cancer patients.
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 to efficiently develop
the compound for use in oncology. For more information, please
visit Aeolus’ corporate website at www.aeoluspharma.com.
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 and any potential future submissions or
applications to the FDA. 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, receipt of funding under the contract with BARDA, 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’ Annual Report on Form 10-K for the year
ended September 30, 2009. 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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