The Treatment of Dengue Hemorrhagic Fever; Report Released by Aethlon Medical, Inc.
November 02 2006 - 1:15PM
Business Wire
Aethlon Medical, Inc. (OTCBB:AEMD), a pioneer in developing
therapeutic devices for infectious disease, disclosed today that
Chairman and CEO James A. Joyce has authored a report entitled The
Treatment of Dengue Hemorrhagic Fever. The content of the report
follows: Summary Dengue Virus and virulent Dengue Hemorrhagic Fever
(DHF) represent an international health issue that remains
untreatable with traditional antiviral drug and vaccine therapy.
This document summarizes the application of the Aethlon
HemopurifierTM as a broad-spectrum therapeutic device able to clear
dengue virus from infected patients, and potentially assist in the
modulation of inflammatory cytokines associated with advanced DHF.
The global prevalence of dengue has grown dramatically in recent
decades. The disease is now endemic in more than 100 countries, and
according to the World Health Organization, as many as 50 million
cases of dengue infection occur each year. Background of the
HemopurifierTM Many viral pathogens, including Dengue, are not
treatable with antiviral drug or vaccine therapy. When therapies do
evolve, viruses often mutate to become resistant to treatment.
Viruses that cross over from animal species into man compound the
treatment challenge. Recent examples of such zoonotic transmission
include HIV, SARS, West Nile, Ebola, Marburg, and most recently the
H5N1 strain of Avian Influenza. Genetic modification of viruses
with the intent to create drug and vaccine resistant bioterror
threats minimize the likelihood that traditional therapeutics will
keep pace. The Aethlon HemopurifierTM is a first-in-class device
designed to fill the void in treating many drug and vaccine
resistant pathogens. The technology promises to augment the benefit
of drug therapy when available, and serves as a first line
countermeasure in the absence of drug or vaccine treatments. The
technology converges the blood filtration principles established in
hemodialysis and plasmapheresis with the immobilization of affinity
agents that capture envelope viruses by the surface carbohydrate
structures they have evolved to evade the natural immune response.
As a result, the HemopurifierTM is able to reduce the body burden
of infectious virus and related toxins, thus increasing the
likelihood that a patient�s own immune response can overcome
infection. Aethlon recently completed a 24-treatment safety study
of the HemopurifierTM in health compromised dialysis patients
co-infected with Hepatitis-C virus. The study was administered at
the Apollo Hospital in New Delhi, India. The resulting data has led
to the submission of a preliminary Investigational Device Exemption
with The Food and Drug Administration (FDA) related to the use of
the HemopurifierTM in the United States as a broad-spectrum
countermeasure against class `A' bioweapon threats and pandemic
influenza. Aethlon plans further clinical programs in India, and
has initiated discussions with the Indian Council of Medical
Research (ICMR) and other agencies related to the treatment of DHF
and other viral conditions. In the capital city of New Delhi alone,
67 of the 2,640 persons known infected with Dengue since late July
have died. The Dengue Threat DHF is one of the greatest infectious
disease threats known to man. DHF infection is transmitted through
mosquito-borne Dengue viruses (serotypes 1- 4). The severe form of
the disease, Dengue Hemorrhagic Fever � Dengue Shock Syndrome
(DHF/DSS), is one of the leading causes of hospitalization and
death among children in Asia, with the average case-fatality rate
being approximately 17%. Since the description of Dengue etiology
in 1944, considerable effort has been put into vaccine development,
with significant development challenges encountered. Included among
these challenges is the reality that Dengue virus infection of one
subtype actually enhances the severity of disease caused by
infection with another subtype. The first infection causes a
relatively mild dengue fever. A subsequent infection, if it
involves another subtype, causes DHF/DSS, while a third infection
involving a third subtype, is almost always fatal. In addition to
the direct effects of the viral infection, advanced DHF can trigger
viral sepsis leading to the overproduction of deleterious
cytokines. Evidence also exists that alpha and beta interferon
(IFN-alpha) and gamma IFN (IFN-beta) may be involved. As such, the
development of an effective DHF treatment remains elusive. The
HemopurifierTM as a Treatment for Dengue Hemorrhagic Fever The
HemopurifierTM has been designed to isolate and capture highly
pathogenic viruses and emerging viral threats. At present, it
represents the only proposed treatment for DHF that simultaneously
targets broad-strain clearance of Dengue virus and also assists in
the modulation of excessive cytokine activity. The deployment of
the HemopurifierTM as a treatment for DHF is consistent with
Aethlon�s corporate strategy to collaborate with government and
corporate entities to develop the Hemopurifier as a broad-spectrum
treatment for drug and vaccine resistant pathogens. Specific to
DHF, the HemopurifierTM serves as an extracorporeal method to
augment the immune response, thereby improving the likelihood that
the natural immune response can overcome infection. Attributes and
considerations for deploying the HemopurifierTM as a treatment for
DHF, include: Rapid Clearance of DHF - The affinity agents
immobilized within the HemopurifierTM have broad-spectrum
capabilities to capture envelope viruses by binding to glycosolated
proteins that reside on viral surfaces. In the case of DHF, the
virus capture is directed at surface glycoproteins, which are
available binding sites, even in the case of viral mutation. In
pre-clinical testing, the affinity agent immobilized in the
HemopurifierTM has demonstrated the ability to bind to a prominent
Dengue surface protein. The ability to clear Dengue virus and viral
fragments prior to cell and organ infection is likely to inhibit
disease progression. In regards to broad-spectrum capability, the
Hemopurifier has demonstrated the capture of HIV, HCV, and Orthopox
viruses related to human smallpox. Researchers at the National
Cancer Institute (NCI) and the National Institutes of Health (NIH)
have documented that the form of affinity agents immobilized in the
Hemopurifier also have activity against other viral pathogens
including Marburg, Ebola, and Influenza. Broad Clearance of
Cytokines - The structure of the HemopurifierTM provides for the
potential to modulate the overproduction of deleterious cytokines.
In fact, hemofiltration techniques have been indicated as an
adjunct treatment for cytokine induced sepsis since 1990. As such,
the HemopurifierTM may be an ideal method to assist in cytokine
modulation, as the pores of the HemopurifierTM fibers are large
enough to allow both cytokines and cytokine aggregates unable to be
cleared in Hemofiltration, to be removed from circulation. In
closing, the Aethlon HemopurifierTM offers to increase
survivability of those afflicted with DHF. Season epidemic
outbreaks of Dengue are now underway in various regions around the
world, including India, where the most serious resurgence of Dengue
infection since 1996 is occurring. In the absence of a vaccine and
effective antiviral drugs, Aethlon Medical will collaborate with
heath agencies of governments that seek to advance the
HemopurifierTM as a treatment option for their citizens infected
with DHF. About Aethlon Medical Aethlon Medical has developed the
first-in-class medical device to treat infectious disease. The
device, known as the Hemopurifier�, is a broad-spectrum treatment
countermeasure against drug and vaccine resistant bioweapons,
naturally evolving pandemic threats such as H5N1 Avian Flu, and
chronic infectious disease targets including Hepatitis-C (HCV) and
the Human Immunodeficiency Virus (HIV). Global researcher, Frost
& Sullivan, recently awarded the HemopurifierTM the 2006
Technology Innovation Award for its advances in the field of
biodefense. Aethlon has also initiated research on a second
generation HemopurifierTM that targets the capture of growth
factors inherent in the spread of Cancer. More information on
Aethlon Medical and the HemopurifierTM technology can be found at
www.aethlonmedical.com. Certain of the 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, the Company�s ability to raise capital when needed, the
Company�s ability to complete the development of its planned
products, the ability of the Company to obtain FDA and other
regulatory approvals permitting the sale of its products, the
Company�s ability to manufacture its products 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. Aethlon
Medical, Inc. (OTCBB:AEMD), a pioneer in developing therapeutic
devices for infectious disease, disclosed today that Chairman and
CEO James A. Joyce has authored a report entitled The Treatment of
Dengue Hemorrhagic Fever. The content of the report follows:
Summary Dengue Virus and virulent Dengue Hemorrhagic Fever (DHF)
represent an international health issue that remains untreatable
with traditional antiviral drug and vaccine therapy. This document
summarizes the application of the Aethlon Hemopurifier(TM) as a
broad-spectrum therapeutic device able to clear dengue virus from
infected patients, and potentially assist in the modulation of
inflammatory cytokines associated with advanced DHF. The global
prevalence of dengue has grown dramatically in recent decades. The
disease is now endemic in more than 100 countries, and according to
the World Health Organization, as many as 50 million cases of
dengue infection occur each year. Background of the
Hemopurifier(TM) Many viral pathogens, including Dengue, are not
treatable with antiviral drug or vaccine therapy. When therapies do
evolve, viruses often mutate to become resistant to treatment.
Viruses that cross over from animal species into man compound the
treatment challenge. Recent examples of such zoonotic transmission
include HIV, SARS, West Nile, Ebola, Marburg, and most recently the
H5N1 strain of Avian Influenza. Genetic modification of viruses
with the intent to create drug and vaccine resistant bioterror
threats minimize the likelihood that traditional therapeutics will
keep pace. The Aethlon Hemopurifier(TM )is a first-in-class device
designed to fill the void in treating many drug and vaccine
resistant pathogens. The technology promises to augment the benefit
of drug therapy when available, and serves as a first line
countermeasure in the absence of drug or vaccine treatments. The
technology converges the blood filtration principles established in
hemodialysis and plasmapheresis with the immobilization of affinity
agents that capture envelope viruses by the surface carbohydrate
structures they have evolved to evade the natural immune response.
As a result, the Hemopurifier(TM) is able to reduce the body burden
of infectious virus and related toxins, thus increasing the
likelihood that a patient's own immune response can overcome
infection. Aethlon recently completed a 24-treatment safety study
of the Hemopurifier(TM) in health compromised dialysis patients
co-infected with Hepatitis-C virus. The study was administered at
the Apollo Hospital in New Delhi, India. The resulting data has led
to the submission of a preliminary Investigational Device Exemption
with The Food and Drug Administration (FDA) related to the use of
the Hemopurifier(TM) in the United States as a broad-spectrum
countermeasure against class `A' bioweapon threats and pandemic
influenza. Aethlon plans further clinical programs in India, and
has initiated discussions with the Indian Council of Medical
Research (ICMR) and other agencies related to the treatment of DHF
and other viral conditions. In the capital city of New Delhi alone,
67 of the 2,640 persons known infected with Dengue since late July
have died. The Dengue Threat DHF is one of the greatest infectious
disease threats known to man. DHF infection is transmitted through
mosquito-borne Dengue viruses (serotypes 1- 4). The severe form of
the disease, Dengue Hemorrhagic Fever - Dengue Shock Syndrome
(DHF/DSS), is one of the leading causes of hospitalization and
death among children in Asia, with the average case-fatality rate
being approximately 17%. Since the description of Dengue etiology
in 1944, considerable effort has been put into vaccine development,
with significant development challenges encountered. Included among
these challenges is the reality that Dengue virus infection of one
subtype actually enhances the severity of disease caused by
infection with another subtype. The first infection causes a
relatively mild dengue fever. A subsequent infection, if it
involves another subtype, causes DHF/DSS, while a third infection
involving a third subtype, is almost always fatal. In addition to
the direct effects of the viral infection, advanced DHF can trigger
viral sepsis leading to the overproduction of deleterious
cytokines. Evidence also exists that alpha and beta interferon
(IFN-alpha) and gamma IFN (IFN-beta) may be involved. As such, the
development of an effective DHF treatment remains elusive. The
Hemopurifier(TM )as a Treatment for Dengue Hemorrhagic Fever The
Hemopurifier(TM) has been designed to isolate and capture highly
pathogenic viruses and emerging viral threats. At present, it
represents the only proposed treatment for DHF that simultaneously
targets broad-strain clearance of Dengue virus and also assists in
the modulation of excessive cytokine activity. The deployment of
the Hemopurifier as a treatment for DHF is consistent with
Aethlon's corporate strategy to collaborate with government and
corporate entities to develop the Hemopurifier as a broad-spectrum
treatment for drug and vaccine resistant pathogens. Specific to
DHF, the Hemopurifier(TM )serves as an extracorporeal method to
augment the immune response, thereby improving the likelihood that
the natural immune response can overcome infection. Attributes and
considerations for deploying the Hemopurifier(TM )as a treatment
for DHF, include: -- Rapid Clearance of DHF - The affinity agents
immobilized within the Hemopurifier(TM) have broad-spectrum
capabilities to capture envelope viruses by binding to glycosolated
proteins that reside on viral surfaces. In the case of DHF, the
virus capture is directed at surface glycoproteins, which are
available binding sites, even in the case of viral mutation. In
pre-clinical testing, the affinity agent immobilized in the
Hemopurifier(TM) has demonstrated the ability to bind to a
prominent Dengue surface protein. The ability to clear Dengue virus
and viral fragments prior to cell and organ infection is likely to
inhibit disease progression. In regards to broad-spectrum
capability, the Hemopurifier has demonstrated the capture of HIV,
HCV, and Orthopox viruses related to human smallpox. Researchers at
the National Cancer Institute (NCI) and the National Institutes of
Health (NIH) have documented that the form of affinity agents
immobilized in the Hemopurifier also have activity against other
viral pathogens including Marburg, Ebola, and Influenza. -- Broad
Clearance of Cytokines - The structure of the Hemopurifier(TM)
provides for the potential to modulate the overproduction of
deleterious cytokines. In fact, hemofiltration techniques have been
indicated as an adjunct treatment for cytokine induced sepsis since
1990. As such, the Hemopurifier(TM) may be an ideal method to
assist in cytokine modulation, as the pores of the Hemopurifier(TM)
fibers are large enough to allow both cytokines and cytokine
aggregates unable to be cleared in Hemofiltration, to be removed
from circulation. In closing, the Aethlon Hemopurifier(TM) offers
to increase survivability of those afflicted with DHF. Season
epidemic outbreaks of Dengue are now underway in various regions
around the world, including India, where the most serious
resurgence of Dengue infection since 1996 is occurring. In the
absence of a vaccine and effective antiviral drugs, Aethlon Medical
will collaborate with heath agencies of governments that seek to
advance the Hemopurifier(TM) as a treatment option for their
citizens infected with DHF. About Aethlon Medical Aethlon Medical
has developed the first-in-class medical device to treat infectious
disease. The device, known as the Hemopurifier(TM), is a
broad-spectrum treatment countermeasure against drug and vaccine
resistant bioweapons, naturally evolving pandemic threats such as
H5N1 Avian Flu, and chronic infectious disease targets including
Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV).
Global researcher, Frost & Sullivan, recently awarded the
Hemopurifier(TM) the 2006 Technology Innovation Award for its
advances in the field of biodefense. Aethlon has also initiated
research on a second generation Hemopurifier(TM) that targets the
capture of growth factors inherent in the spread of Cancer. More
information on Aethlon Medical and the Hemopurifier(TM) technology
can be found at www.aethlonmedical.com. Certain of the 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, the Company's ability to raise capital when needed, the
Company's ability to complete the development of its planned
products, the ability of the Company to obtain FDA and other
regulatory approvals permitting the sale of its products, the
Company's ability to manufacture its products 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.