SAN DIEGO - February 28, 2013 (Investorideas.com newswire) - Aethlon Medical, Inc. (
OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
I recently attended a healthcare related event that featured a
panel discussion comprised of life science bankers and venture
capitalists. While members of this panel often had differing viewpoints,
they did mutually agree they were interested in emerging therapeutic
candidates that provided more than one "shot on goal," meaning the
possibility of a single therapy that could address more than one disease
indication.
In the case of the Aethlon Hemopurifier®, we have created a
therapeutic filtration device that selectively captures a broad-spectrum
of disease promoting particles from circulation without eliminating
blood components required for health. However, instead of immobilizing
an antibody or agent that specifically binds to a single pathogen, we
made the bold decision to deploy the capabilities of a lectin affinity
agent that binds to a unique structure evolved and shared by viruses and
cancer as a survival mechanism that allows disease progression to
continue below the surveillance of the immune system. In the treatment
of Hepatitis C virus (HCV), we have demonstrated that our Hemopurifier®
can eliminate the presence of HCV in as little a seven days when
utilized in combination with interferon-based therapy. Short-term
administration of the same device has reduced viral load by greater than
90% in an HIV-AIDS dialysis patient who was not receiving any form of
antiviral drug therapy. Additionally, government and non-government
research organizations have demonstrated the Hemopurifier® captures a
wide range of bioterror and pandemic threats. In regards to cancer, the
same Hemopurifier® deployed in infectious disease studies has emerged
to be the first therapeutic strategy to address tumor-secreted exosomes.
Tumor-secreted exosomes are a vital therapeutic target as they have
recently been discovered to be immunosuppressive and play significant
role in seeding the creation and spread of cancer metastasis.
So, how is it possible that one therapy can address a breadth of
disease conditions? Dr. Annette Marleau, our Director of Tumor
Immunology provides the following summary review for interested parties,
including medical and non-medical industry shareholders of Aethlon
Medical:
Intriguingly, there are converging biological mechanisms underlying
viral infections and cancer, despite the fact that these are distinct
categories of disease that are typically addressed with different
therapies. Common disease processes in infections and cancer include
the modalities by which disease is spread and the involvement of the
immune system. The latter point stems from the fact that both tumor
cells and infectious pathogens are viewed as "foreign invaders" by the
immune system. In response, diseased cells have evolved tactics for
manipulating the immune system to their advantage in order to propagate
disease. One of the key pathogenic maneuvers employed by viruses and
tumors is the systemic distribution of disease-mediating particles that
spread molecular information from diseased cells to healthy cells.
Of relevance to our Hemopurifier® is the observation that critical
disease-mediating particles in many viral infections and cancer display
high-mannose glycoproteins on their surfaces. These surface features
arise during the process of glycosylation, whereby carbohydrate residues
such as mannose are tagged onto proteins to ensure proper protein
assembly and function in healthy cells. Not surprisingly, this process
becomes perturbed in several disease conditions, thereby changing the
biologic functions of proteins. To define the glycoprotein signatures
associated with specific disease conditions, researchers have applied
panels of carbohydrate-binding proteins (lectins) to determine the
relative compositions of specific carbohydrate residues in cellular
material. Extrapolating on the use lectins as research reagents for
biomarker discovery, our device platform leverages the specificity of
lectins for glycoprotein-coated particles for therapeutic affinity
capture.
Among the spectrum of targets of the Hemopurifier® are enveloped
viruses, a broad group of infectious pathogens that are enriched for
high-mannose glycoproteins on their outer surfaces. The envelope
glycoproteins have well-recognized roles in viral attachment and
integration into host cells (1). Scientific studies have demonstrated
that lectins have potent anti-viral activity by virtue of their
interference with the functions of envelope glycoproteins. Indeed, the
current version of the Hemopurifier® has been demonstrated to capture a
spectrum of enveloped viruses including HIV, Dengue virus,
orthopoxviruses (vaccinia and monkeypox), influenza viruses (H5N1 bird
flu, 1918 Spanish flu), and Ebola.
In addition to addressing viral infections, the Hemopurifier also
captures cancer-derived exosomes that also display high-mannose
glycoproteins on their outer surfaces (2). Exosomes are membranous
nanovesicles secreted by diverse tumor types that act as inter-cellular
messengers to spread oncogenic signals. Evidence is emerging that cancer
exosomes are involved in practically every aspect of malignancy,
including apoptosis of immune cells, tissue invasion, angiogenesis,
metastases and resistance to therapeutic drugs. The genomic and
proteomic content of exosomes, as well as the exosome load in the
circulation, are known to correlate with tumor stage and metastasis,
suggesting that exosomes can serve as disease biomarkers (3,4).
Accordingly, exosomes have emerged as critical targets in cancer care,
and there is currently an unmet need for means of targeting these
nanovesicles therapeutically.
Based on their common glycoprotein signatures, the biogenesis of
virions and exosomes has been suggested to share a conserved
evolutionary pathway (5). These nano-sized particles (both in the
50-300 nm range) use their heavily glycosylated surfaces for entry into
target cells, where virions and exosomes transfer pathogenic information
in the form of proteins and/or genetic material. These particles also
hijack the intracellular machinery to affect cell growth and survival
pathways, while also promoting the formation of more disease-mediating
particles. Indeed, newly generated virions and exosomes are both
secreted by budding off from the plasma membrane of diseased cells,
during which time it is believed they inherit glycoprotein-rich membrane
components (6). Thus, the fields of viral and cancer immunology
converge mechanistically at the level of the glycoprotein "fingerprints"
on key disease-mediating particles.
The intersection of the pathways exploited by virions and exosomes
is exemplified by the ability of certain viruses to package their
infectious material into exosomes. For example, HIV-infected cells
secrete exosomes containing Nef or "Negative Factor", an abundant HIV
protein that induces death of CD4+ T cells, a hallmark of AIDS (7).
Viruses and exosomes can therefore act as co-dependent entities for
spreading infection and impeding host immunity. A validation study
conducted by our collaborators at the Morehouse School of Medicine
revealed that the Hemopurifier® captures NEF exosomes and therefore
holds promise as an anti-viral strategy for co-targeting both Nef
exosomes and HIV virions in circulation.
Collectively, these lines of evidence provide a compelling
scientific rationale for why the Hemopurifier® is a candidate
broad-spectrum countermeasure against both viral pathogens and cancer.
In both of these clinical scenarios, we propose to advance the
Hemopurifier as an adjunct to standard of care therapies for reducing
the systemic burden of disease-mediating particles and unmasking the
native immune response in patients.
(1) Balzarini J. Targeting the glycans of glycoproteins: a novel paradigm for antiviral therapy. Nat Rev Microbiol 2007;5:583.
(2) Batista BS et al. Identification of a conserved glycan signature for microvesicles. J Proteome Res 2011;10:4624.
(3) Taylor DD and Gercel-Taylor C. Exosomes/microvesicles:
mediators of cancer-associated immunosuppressive microenvironments.
Semin Immunopathol 2011;33:441.
(4) Henderson MC and Azorsa DO. The genomic and proteomic content of cancer cell-derived exosomes. Front Oncol 2012;2:38.
(5) Krishnamoorthy L et al. HIV-1 and microvesicles from T cells
share a common glycome, arguing for a common origin. Nat Chem Biol
2009;5:244.
(6) Wurdinger T et al. Extracellular vesicles and their convergence with viral pathways. Adv Virol 2012:767694.
(7) Lenassi M et al. HIV Nef is secreted in exosomes and triggers apoptosis in bystander CD4+ T cells. Traffic 2010;11:110.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address
unmet medical needs in cancer, infectious disease, and other
life-threatening conditions. Our Aethlon ADAPT™ System is a
revenue-stage technology platform that provides the basis for a new
class of devices the rapid, yet selective removal of disease promoting
particles from the entire circulatory system. At present, The Aethlon
ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address
infectious disease and cancer, and a medical device being developed
under a 5-year contract with Defense Advanced Research Projects Agency
(DARPA) to reduce the incidence of sepsis in combat-injured soldiers.
For more information, please visit
www.aethlonmedical.com.
About The Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device that
selectively targets the rapid clearance of infectious viral pathogens
and immunosuppressive proteins from the entire circulatory system. In
the treatment of Hepatitis C virus (HCV), human studies have
demonstrated that Hemopurifier® therapy may improve immediate, rapid and
sustained virologic response rates when administered in the first few
days of standard-of-care drug therapy. In addition to accelerating viral
load depletion, post-treatment analysis of the Hemopurifier® has
documented the capture of up to 300 billion HCV copies of HCV during a
single six-hour treatment. Access to Hemopurifier® therapy is available
on a compassionate-use basis through the Medanta Medicity Institute
(Medicity), a leading center for medical tourism in India. The Medicity
is offering treatment access to infected individuals who previously
failed or subsequently relapsed standard-of-care drug regimens. The
Hemopurifier® is also being offered as a salvage therapy to infected
individuals who suffer a viral breakthrough during standard-of-care
therapy. U.S. studies of the Hemopurifier® are currently pending
approval of an IDE submitted to FDA.
The Aethlon Hemopurifier® and Cancer
In addition to the opportunity to address a broad-spectrum of
infectious viral pathogens, the Hemopurifier® has been discovered to
capture tumor-derived exosomes underlying several forms of cancer.
Tumor-derived exosomes have recently emerged to be a vital therapeutic
target in cancer care. These microvesicular particles suppress the
immune response in cancer patients through apoptosis of immune cells and
their quantity in circulation correlates directly with disease
progression. Beyond possessing immunosuppressive properties,
tumor-derived exosomes facilitate tumor growth, metastasis, and the
development of drug resistance. By addressing this unmet medical need,
the Hemopurifier® is positioned as an adjunct to improve established
cancer treatment regimens.
Certain statements herein may be forward-looking and involve risks
and uncertainties. Such forward-looking statements involve assumptions,
known and unknown risks, uncertainties and other factors which may
cause the actual results, performance or achievements of Aethlon
Medical, Inc. to be materially different from any future results,
performance, or achievements expressed or implied by the forward-looking
statements. Such potential risks and uncertainties include, without
limitation, that the company can successfully protect its intellectual
property, that removal of exosomes from the human body will impact or
lead to successful treatment of cancer, or that exosomes are the cause
of tumor growth and progression, that the FDA will not approve the
initiation of the Company's clinical programs or provide market
clearance of the company's products, future human studies whether
revenue or non-revenue generating of the Aethlon ADAPT™ system or the
Aethlon Hemopurifier® as an adjunct therapy to improve patient
responsiveness to established cancer or hepatitis C therapies or as a
standalone cancer or hepatitis C therapy, 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 and provide its
services, the impact of government regulations, patent protection on the
Company's proprietary technology, product liability exposure,
uncertainty of market acceptance, competition, technological change, and
other risk factors. In such instances, actual results could differ
materially as a result of a variety of factors, including the risks
associated with the effect of changing economic conditions and other
risk factors detailed in the Company's Securities and Exchange
Commission filings. The Company undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a result of
new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com Newswire
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with Sedar. Read for more info:
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According to the release, "Under the terms of the new agreement,
the diversified national insurer will offer the Company's MediPendant®
product and monthly monitoring services to subscribers of selected
healthcare programs. Additionally, the Company's MediPendant® product
has been, or may be, included in their dual demonstration programs
(Medicare and Medicaid) related contracts on which Coventry Health Care,
Inc.( NYSE:CVH )
may bid. Additional information regarding this contract can be viewed
on the website hosted by the US Securities & Exchange Commission at
the following link:" http://www.sec.gov/Archives/edgar/data/1443089/000147124213000073/mdhifeb262013.htm
About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:
According to the release, "Under the terms of the new agreement,
the diversified national insurer will offer the Company's MediPendant®
product and monthly monitoring services to subscribers of selected
healthcare programs. Additionally, the Company's MediPendant® product
has been, or may be, included in their dual demonstration programs
(Medicare and Medicaid) related contracts on which Coventry Health Care,
Inc.(