Medical Technology News: Aethlon Medical (Nasdaq:
$AEMD) Announces Zika Virus Data
In vitro
studies that demonstrate the rapid capture of Zika virus by the Aethlon
Hemopurifier
SAN DIEGO, CA, August 11, 2016 -- (Investorideas
Newswire) Aethlon Medical, Inc. (Nasdaq:AEMD), a developer of immunotherapeutic
technologies to combat infectious disease and cancer, announced today that its
researchers have completed in vitro
studies that demonstrate the rapid capture of Zika virus by the Aethlon
Hemopurifier®. The Hemopurifier® is a leading broad-spectrum treatment
countermeasure against viral pathogens that are untreatable with or resistant
to antiviral drug therapies. At present,
the immunotherapeutic technology is being advanced through an FDA approved
human feasibility study. The Zika
studies, which were conducted with small-scale versions of the Hemopurifier®,
demonstrated a 95% clearance of Zika virus from cell culture fluid in 5.5 hours
and an approximate 50% clearance of Zika from human blood serum in 5
hours.
The studies were conducted with the Zika
viral strain that has recently spread from South America to ravage Puerto Rico
and likely responsible for the first wave of infections that have begun to
occur in the United States. Zika has
been declared a global health threat by the World Health Organization and is
not addressed with a proven drug or vaccine therapy. According to the CDC, more than 7,300
Americans have been diagnosed with Zika virus infection, including 1,825 individuals in the continental U.S. and Hawaii. Researchers have linked Zika virus infection
with Guillain-Barre syndrome, a severe neurological disorder that can cause
paralysis. In pregnant women, Zika can cause Microcephaly, which results in babies being
born with a small head and underdeveloped brain. Zika infection has also been
associated with Arthrogryposis, a condition that results in deformities of
joints in the arms and legs of newborns.
"As a result of our
research team’s validation of Zika capture, we have further reinforced the
potential of our Hemopurifier® to be a first line of defense against the
growing list of infectious viral pathogens that are not addressed with
traditional drug or vaccine therapies," stated Aethlon Chairman and CEO, Jim
Joyce.
Aethlon also disclosed that it entered
into an agreement with the Defense Advanced Research Projects Agency (DARPA) to
validate the in vitro capture of the Middle East Respiratory Syndrome
Coronavirus (MERS-CoV), which was discovered to be infectious to man in 2012
and has an approximate 30% mortality rate.
Like Zika virus, MERS-CoV is not addressed with a proven drug or
vaccine. The agreement is based on the
modification of a contract milestone underlying the Company’s participation in
DARPA’s Dialysis-Like Therapeutics program.
Broad-Spectrum Virus Capture Validations
Zika virus is the most recent of four
significant arboviruses that have spread to the Western Hemisphere. It follows Dengue, which first emerged
aggressively in the 1990s; West Nile virus, which emerged in 1999; and
Chikungunya, which emerged in 2013. "Arbovirus" is a descriptive term
applied to hundreds of predominantly RNA viruses that are transmitted by
arthropods, most notably through mosquitoes.
As a result of the Zika study, the Hemopurifier® has now demonstrated
the capture of each of these four arboviruses.
Beyond Zika, Dengue, Chikungunya and
West Nile virus, the Hemopurifier has also been validated to capture Monkey
pox, which serves as models for human Smallpox infection. Specific to pandemic influenza threats, the
Hemopurifier has been validated to capture the H5N1 avian flu virus, H1N1 swine
flu virus, and the reconstructed 1918 influenza virus, which represents a model
for the strain of influenza that killed an estimated 50 million victims.
Human Treatment Experiences
In regards to human studies,
Hemopurifier therapy has previously been administered to individuals infected
with Ebola, Hepatitis C and HIV. In the
case of Ebola, the successful treatment of a comatose physician with multiple
organ failure contributed to the emergency use clearance of the Hemopurifier®
by the FDA and the government of Canada.
About Aethlon Medical
Aethlon Medical (Nasdaq: 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.
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, 2015, 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.
Contacts:
Mike Smargiassi/Brad Edwards
Brainerd Communicators, Inc.
212-986-6667
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