Aethlon Medical Discloses New HIV/AIDS Treatment Data
May 05 2009 - 9:03AM
PR Newswire (US)
SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc.
(OTC Bulletin Board: AEMD) today disclosed new data resulting from
its recent "first-in-human" application of the Aethlon
Hemopurifier(R) to treat Human Immunodeficiency Virus (HIV), the
disease that causes Acquired Immune Deficiency Syndrome (AIDS).
Aethlon announced that an HIV-infected individual, who received
twelve Hemopurifier(R) treatments during the span of one month, had
an average viral load reduction of 55% during each four-hour
Hemopurifier(R) treatment. The study was conducted in the absence
of any antiviral drug therapy. Based on this data, mathematical
treatment models of approximately 1.5 days of continuous
Hemopurifier(R) treatment would reduce patient viral load to
undetectable levels. The study, which was conducted at the Sigma
New Life Hospital in Punjab, India, was designed to provide insight
that will define future clinical programs and commercialization
pathways for the Aethlon Hemopurifier(R). (Logo:
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b) "Our
initial observations from the HIV study validated that our
Hemopurifier(R) could inhibit and reverse HIV disease progression
in the absence of antiviral drugs," stated Aethlon Chairman and
CEO, Jim Joyce. "We now have additional insight that suggests we
could quickly reset viral loads to undetectable levels, which
supports our belief that the Hemopurifier(R) could significantly
enhance and extend the efficacy of both established and candidate
drug regimens," concluded Joyce. The Hemopurifier(R) is a
first-in-class medical technology that assists the immune response
in combating infectious disease through the selective adsorption of
circulating viruses and immunosuppressive proteins. In HIV care,
the Hemopurifier(R) targets the clearance of all circulating
strains of infectious HIV, including varieties that cause patients
to fail antiviral drug regimens. Additionally, the device assists
to preserve the immune response through the removal of gp120 and
other toxic proteins that shed from HIV to kill-off immune cells,
the hallmark of AIDS. Since the beginning of 2009, the
Hemopurifier(R) has been demonstrated safe and effective in
reducing patient viral load in both Hepatitis-C Virus (HCV) and
Human Immunodeficiency Virus (HIV) infections. As a result, Aethlon
believes the Hemopurifier(R) is the first therapeutic candidate to
demonstrate viral reduction benefit against two different viral
species in human studies. Aethlon previously reported that viral
load was reduced by 92% in the HIV-infected individual treated in
the Hemopurifier(R) based on initial viral load of 102,759 iu/ml
being reduced to 7,960 iu/ml at the conclusion of the study. The
subject patient had end-stage renal disease (ESRD) and was
clinically defined as having AIDS based on a CD4+ T-cell percentage
of total lymphocytes of 13.5% at the outset of Hemopurifier(R)
therapy. A percentage below 14% is a defining event that indicates
HIV infection has progressed to AIDS. By the end of the
Hemopurifier(R) study, CD4+ T-cell percentage of total lymphocytes
increased to 18.09%. Corresponding CD4 lymphocyte counts decreased
from 215 cells/uL to 168 cells/uL. Post study follow-on testing
indicated that HIV viral load was 57% lower (43,398 iu/ml) than
initial study values when measured 14-days after administration of
the last Hemopurifier(R) treatment. The principal investigator of
the study reported the patient felt an improved sense of well
being, including increased energy and appetite during the study.
There were no observed adverse events reported by the principal
investigator. All viral load measurements were performed with
real-time quantitative polymerase chain reaction (RT-PCR), with
treatment samples being measured in duplicate. The outcome of the
study fulfilled the challenge underlying a recent grant submission
to the Bill & Melinda Gates Foundation to demonstrate that an
artificial adjunct to the immune system can reduce viral load and
improve immune function in an HIV infected individual. Aethlon has
been advised by the Gates Foundation that it not a recipient of a
Grand Challenges II grant but has been encouraged to refine its
proposal and resubmit for a Gates Foundation Grand Challenges III
Global Health grant. According to the World Health Organization, an
estimated 33 million people worldwide are infected with HIV, the
virus that causes AIDS, and last year 2.2 million people died of
AIDS-related illnesses. While there is no cure, HIV antiviral drug
regimens have allowed people to live longer with HIV infection.
Over time, resistance to these medications can evolve to eliminate
the benefit of antiviral drugs, thus leaving infected individuals
without further treatment options. About Aethlon Medical Aethlon
Medical creates diagnostic and therapeutic filtration devices to
improve the health of individuals afflicted with infectious disease
and cancer. Aethlon's lead product, the Hemopurifier(R), is a
first-in-class artificial adjunct to the immune system proven to
capture infectious viruses and immunosuppressive particles from the
human circulatory system. The device targets to inhibit disease
progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency
Virus (HIV), and serves as a broad-spectrum treatment
countermeasure against bioterror and emerging pandemic threats. The
Hemopurifier(R) also holds promise in cancer care, as research
studies verify the Hemopurifier(R) effectively captures
immunosuppressive exosomes that are secreted by tumors to kill-off
immune cells. At present, over sixty-five (65) Hemopurifier(R)
treatments (representing approximately 260 hours of treatment time)
have been conducted in multi-site studies at the Apollo Hospital,
Fortis Hospital, and Sigma New-Life Hospital in India. The studies
enrolled end-stage renal disease (ESRD) patients infected with
either HCV or HIV. In addition to establishing treatment safety,
robust viral load reductions have been reported in both HCV and HIV
infected individuals. Research studies have also demonstrated the
Hemopurifier(R) is effective in capturing a broad-spectrum of
viruses untreatable with drug therapy, including several of world's
deadliest bioterror and pandemic threats. These include: Dengue
hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF), Lassa
hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), the
reconstructed 1918 influenza virus (r1918), West Nile virus (WNV),
and Vaccinia and Monkeypox (MPV), which both serve as models for
human smallpox infection. The studies were conducted with the
assistance of researchers representing: The U.S. Army Medical
Research Institute of Infectious Diseases (USAMRIID); The Centers
for Disease Control and Prevention (CDC); The National Institute of
Virology (NIV); The Battelle Biomedical Research Center (BBRC); and
The Southwest Foundation for Biomedical Research (SFBR). Beyond
therapeutic market opportunities, Aethlon is leveraging principles
underlying the Hemopurifier(R) technology platform to establish a
pipeline of clinical and research diagnostic products and services.
Additional information regarding Aethlon Medical can be accessed
online at http://www.aethlonmedical.com/. Contacts: Dave Gentry or
Jon Cunningham RedChip Companies Inc. (407) 644-4256 (407) 491-4498
-cell Jim Joyce Chairman, CEO 858.459.7800 x301 Jeff Richardson
Senior Director, Communications 858.459.7800 x302 Jim Frakes Senior
VP Finance 858.459.7800 x300 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 capability of the Hemopurifier(R) to reduce viral
loads and other disease conditions, 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.
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b
http://photoarchive.ap.org/ DATASOURCE: Aethlon Medical, Inc.
CONTACT: Dave Gentry or Jon Cunningham, RedChip Companies Inc.,
+1-407-644-4256, cell, +1-407-491-4498, , for Aethlon Medical,
Inc.; or Jim Joyce, Chairman, CEO, ext. 301, , or Jeff Richardson,
Senior Director, Communications, ext. 302, , or Jim Frakes, Senior
VP Finance, ext. 300, , all of Aethlon Medical, Inc.,
+1-858-459-7800 Web Site: http://www.aethlonmedical.com/
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