Aethlon Hemopurifier(R) Effective in Capturing West Nile Virus
06 May 2008 - 9:30PM
Business Wire
Aethlon Medical, Inc. (OTCBB:AEMD) today announced that
pre-clinical studies have documented that the Aethlon Hemopurifier�
is effective in capturing circulating West Nile Virus (WNV). The
study data further supports the potential use of the Hemopurifier�
as a broad-spectrum treatment against viral pathogens, whether
naturally occurring, or purposely released as biological weapons of
mass destruction. During in vitro studies, high concentrations of
WNV (approximately 700 thousand WNV/ml) were depleted from cell
culture fluids when circulated through the Hemopurifier�. The study
data indicated that the Hemopurifier� removed 53 percent of
infectious WNV in the first four hours of the testing; 79 percent
at six hours; and 99.3 percent after 20 hours. The studies were
conducted in triplicate, and data verification was provided by
real-time polymerase chain reaction (PCR). �The WNV study
reinforces the stature of our Hemopurifier� as a leading
broad-spectrum treatment candidate for viral pathogens, and further
demonstrates the potential to fill the void in treating yet another
infectious disease condition not addressed by vaccines or antiviral
drug therapies,� stated James A. Joyce, chairman and CEO of Aethlon
Medical. West Nile Virus is considered a Category �B� bioterror and
pandemic threat by the National Institute of Allergy and Infectious
Diseases (NIAID). It was first documented in the Western hemisphere
in 1999, believed to have entered via an infected bird or mosquito,
the common vectors. Incidence of infection in the U.S. has since
increased with approximately 3,600 cases reported in 2007, 33
percent of which were classified as a neuroinvasive disease, the
most severe form of WNV, and resulted in 121 fatalities. Health
officials believe that there is significant underreporting of WNV
infection. At present there is no vaccine to protect against WNV,
nor is there any specific treatment procedure to manage the disease
upon infection. Data from Aethlon�s WNV study will be included in a
June 4th response to a government contract opportunity entitled
�Application of Platform Technologies for the Development of
Therapeutic Agents for Biodefense�. The contract solicitation
(DMID-NIAID-NIHAI20080022BARDA) represents a partnership between
NIAID and the recently established Biomedical Advanced Research and
Development Authority (BARDA) to award contracts that fund the
development and evaluation of innovative approaches to treat NIAID
category A, B and C bioterror threats. Contract recipients will be
awarded up to five years of funding directed toward activities
including, research, clinical programs, and the establishment of
large-scale manufacturing protocols. A significant emphasis of the
contract solicitation is to aid in the development of
broad-spectrum therapies able to demonstrate effectiveness against
multiple bioterror pathogens and toxins. To reinforce the
broad-spectrum capabilities of the Hemopurifier�, Aethlon�s
contract response will also include supporting pre-clinical data
against; Dengue hemorrhagic fever, Ebola hemorrhagic fever, Lassa
hemorrhagic fever, H5N1 avian influenza (Bird Flu), the
reconstructed 1918 influenza virus, Human immunodeficiency virus
(HIV), Hepatitis-C virus (HCV), and vaccinia and monkeypox, which
both represent models associated with human smallpox infection.
Virtually all of the pathogens considered to be material bioterror
threats are untreatable with traditional drug and vaccine
therapies. Effective treatments are either non-existent, of limited
usefulness, or vulnerable to both naturally emerging and
intentionally engineered pathogens. Innovative therapies offering
broad-spectrum activity against different classes of microbes could
potentially be effective against both traditional and
non-traditional threats. Broad-spectrum therapies also provide the
possibility that a limited number of treatment countermeasures
could replace the need for the staggering number of
pathogen-specific drugs that would be required for emergency use in
bioterror and pandemic threat programs. Additionally,
broad-spectrum strategies that are able to overcome drug resistance
could extend the clinical utility of existing therapies. For these
reasons, the U.S. Department of Health and Human Services (HHS)
recently mandated that therapies able to demonstrate broad-spectrum
effectiveness against multiple pathogens are to be the focal point
of government programs that fund the development and
commercialization of countermeasures against bioterror and pandemic
threats. Aethlon Medical considers the Hemopurifier� to be the
leading broad-spectrum candidate as evidenced by its breadth of
pre-clinical data and human treatment experience. About Aethlon
Medical Aethlon Medical is the developer of the Hemopurifier�, a
first-in-class medical device designed to treat infectious disease.
The Hemopurifier� provides real-time therapeutic filtration of
infectious viruses and immunosuppressive particles, and is
positioned to address the treatment of drug and vaccine resistant
viruses. Additionally, the device holds promise in cancer care, as
research studies have verified the Hemopurifier� is able to capture
immunosuppressive particles secreted by tumors. The Hemopurifier�
is designed to act both as a stand-alone therapeutic, and as an
adjunct treatment to enhance clinical benefit of established
therapies. Pre-clinical studies conducted by researchers
representing leading government and non-government health
organizations both in the United States and abroad have documented
the effectiveness of the Hemopurifier� in capturing from
circulation the viruses that constitute pandemic threats, including
H5N1 Avian Influenza (bird flu), and Dengue Hemorrhagic Fever
(DHF). The company is conducting studies to support the use of the
Hemopurifier� as a broad-spectrum treatment countermeasure against
bioterror threats, including Smallpox, and Ebola, Marburg, and
Lassa hemorrhagic fever. Regulatory and commercialization
initiatives in the United States are presently focused on bioterror
threats, while international initiatives are directed toward
naturally evolving pandemic threats, and chronic infectious disease
conditions including the Human Immunodeficiency Virus (HIV) and
Hepatitis-C (HCV). Aethlon demonstrated the safety of the
Hemopurifier� in a 24-treatment human study at the Apollo Hospital
in Delhi, India, and is currently conducting further human studies
at the Fortis Hospital, also located in Delhi. The company has
submitted an investigational device exemption (IDE) to the U.S.
Food and Drug Administration (FDA) to advance the Hemopurifier� as
a broad-spectrum treatment countermeasure against category �A�
bioterror threats. Additional information regarding Aethlon Medical
and its Hemopurifier� technology is available online 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 that 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. Additionally, there
is no assurance that the Company will be the recipient of funding
awards, grants, or contracts from any government agency. 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.
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