Aethlon Medical (NASDAQ:
$AEMD) CEO Note: The Dilemma in Funding Zika and Other Pandemic Therapies
SAN
DIEGO - September 9, 2016 (Investorideas.com newswire) Aethlon Medical, Inc. (Nasdaq: AEMD), today
released the following note authored by its Chairman and CEO, Jim Joyce.
After
a seven-week vacation, the U.S. Congress and Senate returned to work on Tuesday
and immediately restarted the fight to advance a Zika virus funding program.
Beyond normal political posturing, government officials face the dilemma of
whether to allocate resources to support the advancement of traditional drugs
and vaccines or emerging broad-spectrum therapies. As it relates to viral
pandemics, there is often an assumptive complacency that drug and vaccine cures
are just a matter of spending sufficient capital resources. In reality, the
effort to align a disease-specific drug or vaccine with an emerging pandemic
threat is immensely challenging and not often successful. Especially in the
case of a virulent pathogen that may prohibit human studies from being
conducted to demonstrate treatment efficacy.
Emerging
pandemics represent significant threats to mankind and Zika is just one of many
active pathogen threats not addressed with a traditional drug and vaccine.
Beyond pathogens known to be infectious to man, a proliferation of
international travel, urban crowding and global warming are expected to
accelerate the emergence of new pandemic threats in the future. Then, there is
the issue of pathogens created and released by man as agents of bioterrorism.
Our
government has an opportunity to inspire the biotechnology industry to fuel
innovation through the development of broad-spectrum treatment countermeasures
that can cross the boundaries of treating different strains, species and
families of life-threatening viral pathogens. The facts underlying the
challenge of aligning a disease-specific drug or vaccine with each pathogen
threat reinforces the need for broad-spectrum therapeutic innovation.
Statistical Improbability
It
is statistically improbable for traditional pathogen-specific drugs and
vaccines to be developed, proven to be effective, manufactured and then
delivered in a timeframe necessary to combat a life-threatening bioterror or
pandemic threat. As pathogen outbreaks cannot be predicted, the current
universe of therapeutic developers is extremely limited as there is no
commercial incentive to develop such countermeasures from a business model
perspective.
Conversely,
the U.S. Food and Drug Administration (FDA) reports that hundreds and sometimes
thousands of chemical drug compounds must be made and tested to find one that
can achieve a desirable result without serious side effects. To further support
this statement, the FDA website reports that the Pharmaceutical Research and
Manufacturers of America estimates that only 5 in 5,000 compounds that enter
preclinical testing make it to human testing, and only 1 of those 5 may be safe
and effective enough to be approved. Beyond those statistics, expectations for
traditional countermeasures should further be tempered as each pathogen threat
may require multiple drug mechanisms to address the corresponding pathogen
threat. In regards to Zika, there are likely no more than a handful of
candidate drug compounds that have been proposed to treat the virus.
Too Many Threats
Of
the more than 300 viruses known to be infectious to man, only a small fraction
are addressed with a proven antiviral drug or vaccine countermeasure. It has
been estimated that our government has spent more than $80 billion to defend
against biological threats since 2001. Yet, just one of 13 viruses classified
as "Category A" have been addressed with a treatment countermeasure.
The National Institute for Allergy and Infectious Diseases (NIAID) considers
"Category A" pathogens to be biological agents that pose the highest
risk to national security and public health as they are easily disseminated,
result in high mortality rates, and cause public panic and social disruption.
Furthermore, the development of disease-specific drug and vaccine
countermeasure against unknown viral threats is not possible until the pathogen
has either emerged naturally or been released by man as an agent of
bioterrorism.
Inability to Demonstrate
Effectiveness
Perhaps
the greatest challenge in advancing a disease-specific drug or vaccine is the
inability to ethically or feasibly conduct controlled human studies that
demonstrate treatment efficacy against a virulent threat. As a result,
treatment efficacy is required to be demonstrated in animal models, which in
many cases either don't exist or don't equate to treatment efficacy in humans.
As a result, at-risk populations (those most likely to need protection) such as
pregnant women (a primary treatment target for Zika), children, elderly adults
and those with other underlying medical conditions are not recommended to
receive therapeutic candidates that are not proven to be effective in humans
studies.
A Shift Towards Broad-Spectrum
Treatment Countermeasures
The
challenge of aligning a drug and vaccine with each pathogen threat has already
established an impetus for U.S. government health agencies to support
innovative therapeutic mechanisms that can be deployed against a wide-range of
pathogen threats. Such evidence is best reflected in the 2015 Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and
Implementation Plan (SIP), which describes the priorities that the U.S.
Department of Health and Human Services (HHS) will implement over the next five
years to protect against bioterror and emergency pandemic threats. A primary
objective of the PHEMCE SIP includes the advancement of platform technology
medical countermeasures with broad-spectrum capabilities. We are working to
establish the Aethlon Hemopurifier®, which is being advanced clinically in an
FDA approved study, as a leading broad-spectrum treatment countermeasure.
The
Hemopurifier® is an immunotherapeutic technology designed for the single-use
elimination of infectious viruses from the circulatory system. The technology
provides a post-exposure treatment strategy to mitigate illness, suffering, and
death resulting from exposure to virulent viral pathogens that are often beyond
the reach of drug and vaccine therapies. In addition to Zika virus, in vitro studies
have validated the broad-spectrum capture of numerous viral threats. These
include: Chikungunya, Dengue and West Nile virus, which is currently spreading
in the U.S. and is responsible for numerous deaths. Vaccinia and Monkey pox,
which serve as models for human Smallpox infection, have also been validated.
Specific to pandemic influenza threats, we have validated the capture of H5N1
avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which
killed as many as 50 million individuals. In regards to human studies,
Hemopurifier therapy has been successfully administered to individuals infected
with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus
(HIV).
Additional
studies are currently being conducted to validate the capture of Middle East
Respiratory Syndrome Coronavirus (MERS-CoV), which has a fatality rate of
approximately 40%, and Marburg Virus, which is classified as a "Category
A" bioterror and pandemic threat with a fatality rate exceeding 50%.
Zika
and other emerging pandemic viruses represent a significant threat to mankind.
We believe that broad-spectrum treatment countermeasures that cross the
boundaries of different strains, species and families of viruses, should be the
basis for life-saving innovation that will be necessary to combat emerging
pandemic threats around the globe. With Congress and the Senate now back at
work, the political debate of how to protect against Zika and other pandemics
can now continue.
About Aethlon Medical
Aethlon
Medical (AEMD) is a leading developer of immunotherapeutic technologies to
combat infectious disease and cancer. To augment the body's natural immune
defenses, the Aethlon Hemopurifier® eliminates life-threatening disease targets
that are often shielded from the immune system and not well addressed by
traditional drug therapies. The technology captures circulating viruses,
bacterial toxins and cancer promoting exosomes through affinity attachment to a
unique structure that cloaks these targets from immune detection. At present,
the Hemopurifier® is being advanced under an FDA approved clinical study.
Aethlon is also the majority owner of Exosome Sciences, Inc., a company focused
on the discovery of exosomal biomarkers to diagnose and monitor life-threatening
diseases. Aethlon is part of the Russell Microcap® Index. Additional
information can be found online at www.AethlonMedical.com or you can connect
with us on Twitter, LinkedIn, Facebook and Google+.
The Hemopurifier® in Cancer
Upwards
of ninety percent of all cancer-related deaths are attributed to metastasis;
the spread of cancer from a primary site of origin to other organs or areas of
the body. The mechanism of how tumors metastasize to distant sites in the body
has long been one of cancer's greatest mysteries. That mystery was recently
solved when circulating particles known as tumor-derived exosomes were
discovered to be the seeds that promote the spread and growth of cancer
metastasis.
Aethlon
initiated its tumor-derived exosome research at a time when the medical
community believed exosomes were merely cellular debris with no biological
function. Today, a therapeutic to address tumor-derived exosomes represents a
significant unmet need in cancer care. Aethlon has demonstrated that the
affinity mechanism of the Hemopurifier® can capture tumor-derived exosomes
underlying several forms of cancer, including breast, ovarian and metastatic
melanoma.
Beyond
their role in metastasis, researchers have also published mounting evidence
that tumor-derived exosomes contribute to tumorigenesis (the formation of
cancer), cancer progression, angiogenesis (creation of blood vessels to fuel
tumor growth), immune evasion, and resistance to radiation and chemotherapeutic
drugs. Recent discoveries also reveal that exosomes may contribute to bacterial
and viral pathogenesis, the progression of Alzheimer and Parkinson's diseases,
the spread of prion proteins, and numerous inflammatory conditions.
The Hemopurifier® in Infectious Disease
Emerging
pathogens pose a significant threat to mankind. Of the hundreds of viral
pathogens known to be infectious to man, only a few are addressed with proven
antiviral drug or vaccine therapies. Beyond the looming threat of bioterrorism,
a proliferation of international travel, urban crowding and global warming is
expected to accelerate the emergence of future pandemics. In response, the U.S.
Department of Health and Human Services (HHS) has established an initiative to
support platform technology medical countermeasures with broad-spectrum
capabilities. Based on preclinical studies and human treatment experiences, the
Aethlon Hemopurifier® defines this initiative.
To
date, Hemopurifier therapy has been administered to individuals infected with
Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus
(HIV). In the case of Ebola, a remarkable response to a single administration
of Hemopurifier therapy (comatose physician with multiple organ failure at the
time), led to Time Magazine naming the Hemopurifier to be one of the "Top
25 Inventions" as well as one of the "Eleven Most Remarkable Advances
in Healthcare."
Beyond
human treatment experiences, pre-clinical Hemopurifier studies have validated
the broad-spectrum capture of numerous viral threats. These include:
Chikungunya, Dengue and West Nile virus, as well as Vaccinia and Monkey pox,
which serve as models for human Smallpox infection. Specific to pandemic
influenza threats, Aethlon has validated the capture of H5N1 avian flu, H1N1
swine flu, and the reconstructed 1918 influenza virus, which represents a model
for the strain of influenza that killed an estimated 50 million victims in 1918
and 1919. In vitro studies of other viral threats are ongoing.
Aethlon
has also demonstrated that the Hemopurifier captures the bacteria toxins
lipopolysaccharide (LPS) and lipoteichoic acid (LTA). These studies were
conducted under a contract with the Defense Advanced Research Projects Agency
(DARPA) related to the treatment of sepsis.
About Exosome Sciences
Exosome
Sciences, Inc., in collaboration with majority shareholder Aethlon Medical
(Nasdaq: AEMD), is focused on the discovery of exosomal biomarker candidates to
diagnose and monitor life-threatening diseases. The proprietary Enzyme-Linked Lectin-Specific
Assay (ELLSA™) serves as a platform to isolate exosomal biomarkers from a
wide-range of bodily fluids. In preliminary studies, ELLSA™ demonstrated the
ability to isolate exosomes from urine, which resulted in high-sensitivity
detection of HIV-infection. Specific to neurological disorders, Exosome
Sciences discovered TauSome™, an exosomal biomarker that may be the first
non-invasive candidate to detect Chronic Traumatic Encephalopathy (CTE) in
living individuals. In a study of former National Football League (NFL)
players, TauSome levels were found to be significantly higher as compared to
athlete control subjects who participated in non-contact sports. TauSome levels
also correlated with cognitive decline based standardized tests of memory and
psychomotor speed. Visit www.exosomesciences.com for additional
details.
This
press release contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 that involve risks and uncertainties. Statements containing words
such as "may," "believe," "anticipate,"
"expect," "intend," "plan," "project,"
"will," "projections," "estimate," or similar
expressions constitute forward-looking statements. Such forward-looking
statements are subject to significant risks and uncertainties and actual
results may differ materially from the results anticipated in the
forward-looking statements. Factors that may contribute to such differences
include, without limitation, the Company's ability to maintain its listing on
the Nasdaq Capital Market, or any other national securities exchange, that the
Company or its subsidiary will not be able to commercialize its products, that
the FDA will not approve the initiation or continuation of the Company's
clinical programs or provide market clearance of the Company's products,
including any products relating to the Zika virus, the Company's ability to
raise capital when needed, the Company's ability to complete the development of
its planned products, the Company's ability to manufacture its products either
internally or through outside companies, the impact of government regulations,
patent protection on the Company's proprietary technology, the ability of the
Company to meet the milestones contemplated in its contract with DARPA, product
liability exposure, uncertainty of market acceptance, competition,
technological change, and other risk factors. The foregoing list of risks and
uncertainties is illustrative, but is not exhaustive. Additional factors that
could cause results to differ materially from those anticipated in
forward-looking statements can be found under the caption "Risk
Factors" in the Company's Annual Report on Form 10-K for the year ended
March 31, 2016, and in the Company's other filings with the Securities and
Exchange Commission. Except as may be required by law, the Company does not
intend, nor does it undertake any duty, to update this information to reflect
future events or circumstances.
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