The Treatment of H5N1 Avian Influenza Report: Released by Aethlon Medical
16 March 2006 - 8:05AM
Business Wire
Aethlon Medical, Inc. (OTCBB:AEMD), a pioneer in developing
therapeutic devices for infectious disease, disclosed this
afternoon that Chairman and CEO, James A. Joyce, has authored a
report entitled; The Treatment of H5N1 Avian Influenza. The content
of the report follows: Summary The intent of this paper is to
analyze how current options for treating H5N1 Avian Flu infection
may influence the commercialization of the Aethlon
Hemopurifier(TM), a therapeutic device targeted to modulate the
immune response and capture circulating H5N1 virus. In the face of
an accelerating pandemic, the present void in effective H5N1
treatments may dictate that the Hemopurifier(TM), initially
proposed as a treatment for drug resistant patients, evolves into
an important first-line treatment role. Mounting evidence
explaining why H5N1 is often fatal to those infected with the virus
reinforces the opportunity of the Hemopurifier(TM) as an essential
weapon in the treatment arsenal against Avian Flu. The Threat
Scientists are increasingly worried that the H5N1 strain of Avian
Flu will mutate into a form easily passed between humans,
triggering a global pandemic. It already is unprecedented as an
animal illness in its rapid expansion, and has cost 300 million
farmers more than $10 billion during its initial spread through
poultry around the world. World Health Organization (WHO) officials
claim the H5N1 strain of Avian Flu poses a greater challenge to the
world than any other infectious disease, including AIDS. WHO
officials confirm that 101 of 180 people have died H5N1 infection
as of March 15(h), 2006. In the face of such dire news, researchers
are unraveling the mystery of why the H5N1 strain of the Avian Flu
virus is so lethal. It appears that H5N1 hyper-activates the immune
response, a frightening trait inherent in the worst pandemic killer
known to man, the Spanish Flu of 1918, which caused the deaths of
over 40 million people. To provide perspective, it has taken 25
years for AIDS related deaths to rise to such levels. In the case
of H5N1 infection, viral sepsis leading to major organ failure is
often the cause of death. This is triggered when the immune system
over-responds to infection by releasing a cascade of inflammatory
cells and chemicals in what is known as a "Cytokine Storm". As a
result, the likelihood of death in individuals with robust immune
systems equals or exceeds the immune compromised who are normally
most susceptible to regular seasonal flu strains. Unfortunately,
antiviral drugs are unable to shut off a cytokine storm once it has
been triggered. Current Treatments Antiviral drugs being stockpiled
as part of a global strategy to treat Avian Flu have no therapeutic
value once the cytokine storm has been triggered. At present, only
one antiviral, oseltamivir (Tamiflu) is known to offer some level
of effectiveness against the H5N1 strain of Avian Flu. However,
Tamiflu is indicated as a treatment for normal household varieties
of influenza if administered within 48 hours of first symptoms. The
treatment window for an ultra-virulent H5N1 strain is likely to
narrow considerably. Reports already indicate the potency of
Tamiflu against the avian flu virus is reduced, even when taken
after 24 hours of the first symptoms of the disease. H5N1
resistance to Tamiflu is already being reported in Southeast Asia.
Prolonged incubation combined with a short antiviral treatment
window also concerns researchers. Dr. Tim Uyeki, a medical
epidemiologist with the influenza branch of the Centers for Disease
Control and Prevention (CDC) quoted the following to the Wall
Street Journal; "Patients aren't presenting (symptoms) early in the
illness. If the cytokine storm has already been triggered,
antiviral drugs aren't going to turn it off." A successful global
strategy against H5N1 will, at a minimum, have to rely on
therapeutics that can modulate the overproduction of cytokines. The
March 2, 2006 issue of The Lancet reported that researchers at the
well-regarded Karolinska Institute in Stockholm are proposing the
use of chemotherapy to kill off excess immune cells as a means to
curb the cytokine storm leading to viral sepsis in H5N1 patients.
While the concept may seem radical, researchers are likely to agree
that any treatment able to damp down the immune system might be
helpful. Unfortunately, taming the immune system without destroying
defenses against infection has yet to be demonstrated with drugs.
Until other treatments surface, health officials from the United
States and other nations continue a strategy of stockpiling
Tamiflu. To date, the Department of Health and Human Services (HHS)
has ordered 12.4 million doses of Tamiflu, and expects to have a
stockpile of 20 million doses by the end of 2006. Adjunctive
antiviral therapies able to increase Tamiflu effectiveness will
need to surface if these stockpiles are to offer any hope of
widespread benefit. Regardless, the effectiveness of Tamiflu and
other antiviral drugs ends once the cytokine cascade is triggered.
The Hemopurifier(TM) to Treat Avian Flu The Hemopurifier(TM) is
presently the only proposed treatment for H5N1 Avian Flu that
simultaneously targets the clearance of H5N1 and the modulation of
the cytokine storm. The deployment of the Hemopurifier(TM) as a
treatment for Avian Flu is consistent with a corporate strategy to
evolve the Hemopurifier as a broad-spectrum treatment for drug and
vaccine resistant pathogens. In this context, the Hemopurifier(TM)
was recently awarded the 2006 Technology Innovation Award by global
industry researcher, Frost & Sullivan. Specific to H5N1
infection, the Hemopurifier(TM) represents a novel extracorporeal
method to mimic and boost the immune response, which should improve
the effectiveness of antiviral drugs when deployed as an adjunctive
therapy. Once a cytokine storm has been triggered, the Hemopurifier
could serve as the first and perhaps only option for treating H5N1
infected patients. Attributes and considerations for deploying the
Hemopurifier(TM) as a treatment for pandemic flu, include: -0- *T
1. Rapid Clearance of H5N1 - The affinity agents immobilized within
the Hemopurifier(TM) have broad-spectrum capabilities to capture
envelope viruses by binding to glycosolated proteins that reside on
their surface. In the case of H5N1, the virus capture is directed
at two major surface glycoproteins, the hemagglutinin (HA) and
neuraminidase (NA), which are available binding sites, even in the
case of viral mutation. As compared to normal influenza, longer
periods of incubation and accessibility to circulating virus appear
to be the norm in H5N1 infection. The ability to clear H5N1 virus
and viral fragments prior to cell and organ infection, would
decrease cytokine production, inhibit disease progression, and
improve the effectiveness of Tamiflu and other antiviral drugs. 2.
Broad Clearance of Cytokines - The structure of the
Hemopurifier(TM) vastly improves the potential to clear the full
spectrum of deleterious cytokines, as compared to Hemofiltration
techniques indicated as an adjunct treatment for cytokine induced
sepsis since 1990. In fact, the Hemopurifier(TM) may be an ideal
method to modulate cytokine production, 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 separated and captured from circulation. Non-human studies to
document the capture of cytokines, prevalent in autopsy reports of
H5N1 induced deaths, have been initiated by Aethlon researchers. 3.
Expedited Regulatory Path - Under the Bioterrorism Act of 2002,
pandemic flu therapies can be developed and financed by the Project
BioShield Act. The guidelines require clinical trials to only
demonstrate safety in man, as traditional efficacy studies are not
plausible or ethical in the case with pathogenic influenza. Thus,
the FDA is permitted to accept efficacy data from animal models
related to drug and vaccine submissions. In the absence of an
animal model, the Hemopurifier(TM) is positioned to demonstrate the
capture of viruses and cytokines from human blood through closed
loop studies that replicate human treatment. An Avian Flu Industry
Report published by Griffin Securities, suggests that these
regulatory provisions not only provide an accelerated path to
approval, but could also provide government funding for
stockpiling, representing large commercial opportunities for
companies developing Avian Flu therapies. 4. Human Safety
Observations - H5N1 Avian Flu is not a call to arms to initiate
drug and vaccine research programs. It's a siren to deliver
therapeutics that are in late stage development and can be
delivered to market. The proposed treatment of H5N1 with the
Aethlon Hemopurifier(TM) would be based on treatment protocols
already established in a human safety study currently being
administered to renal failure patients co-infected with the
Hepatitis-C virus. To date, no material adverse events have been
observed in these patients. Upon completion of this study, Aethlon
will submit the safety data as part of regulatory submissions to
the Food and Drug Administration (FDA) in an effort to pursue the
treatment of H5N1 Avian Flu and other drug and vaccine resistant
viral conditions. The Company may also seek to commercialize the
Hemopurifier(TM) through regulatory agencies outside of the United
States. *T In closing, the ominous threat of an H5N1 pandemic; the
absence of a vaccine; an evolving resistance to a single drug
option; and, a post-infection immune response that triggers a
highly fatal cytokine storm; provides organizations with innovative
therapeutics, the opportunity to demonstrate effectiveness on a
global stage. Those who execute and deliver therapeutics to the
market will play an important role in saving the lives of
individuals infected with H5N1 pandemic influenza. About Aethlon
Medical Aethlon Medical is developing the first 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). 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.
Atlas Copco (PK) (USOTC:ATLRF)
Historical Stock Chart
From Apr 2024 to May 2024
Atlas Copco (PK) (USOTC:ATLRF)
Historical Stock Chart
From May 2023 to May 2024