The Aethlon Hemopurifier(R) Now Proven to Reduce Both HIV and Hepatitis-C (HCV) Viral Load in Human Studies
SAN DIEGO--(BUSINESS WIRE)--Mar. 11, 2009--
Aethlon Medical, Inc. (OTCBB:AEMD) today announced results of the
“first-in-man” study of the Aethlon Hemopurifier® to treat Human
Immunodeficiency Virus (HIV), the disease that causes Acquired Immune
Deficiency Syndrome (AIDS). In the study, viral load was reduced by 92%
in an HIV-infected individual who received a total of twelve
Hemopurifier® treatments administered thrice weekly over the span of one
month. The study, which was conducted in the absence of any antiviral
drug therapy, documented initial viral load of 102,759 iu/ml being
reduced to 7,960 iu/ml at the conclusion of the study. 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®.
The Hemopurifier® is a therapeutic filtration device that serves as an
artificial adjunct to the immune system. In HIV care the Hemopurifier®
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. Beyond HIV care, the
Hemopurifier® is a leading broad-spectrum treatment candidate against
drug and vaccine resistant viral pathogens.
“Our first HIV treatment experience supports the vision of our
Hemopurifier® becoming a primary strategy to inhibit disease progression
once an individual becomes resistant to antiviral drugs,” stated Aethlon
Chairman and CEO, Jim Joyce. “Additionally, our device offers a
synergistic mechanism of action that could enhance and extend the
benefit of both established and candidate antiviral therapies,”
concluded Joyce.
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.
The individual enrolled in the Hemopurifier® study 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® therapy. A percentage below 14% is a defining event that
indicates HIV infection has progressed to AIDS. By the end of the
Hemopurifier® study, CD4+ T-cell percentage of total lymphocytes
increased to 18.09%. Corresponding CD4 lymphocyte counts decreased from
215 cells/µL to 168 cells/µL. 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® treatment. The principle 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 principle investigator. All viral load
measurements were performed with real-time quantitative polymerase chain
reaction (RT-PCR), with treatment samples being measured in duplicate.
Based on previous treatment outcomes in Hepatitis-C (HCV) infected
patients, Aethlon management believes the Hemopurifier® to be the first
therapeutic candidate to demonstrate meaningful viral load reductions in
both HIV and HCV infected individuals. According to the Centers for
Disease Control and Infection (CDC), about one quarter of HIV-infected
persons are also infected with HCV. HCV is one of the most important
causes of chronic liver disease and HCV infection progresses more
rapidly to liver damage in HIV-infected persons. HCV infection may also
impact the course and management of HIV infection. In addition, HIV
suppression of the immune system reduces patient ability to tolerate the
HCV standard of care.
Beyond the potential to treat individuals infected with both HIV and
HCV, the opportunity for the Hemopurifier® in HCV care is significant,
as approximately 170 million people worldwide (3% of the world's
population) are HCV infected. According to the World Health Organization
(WHO), only 30-50% of infected patients beneficially respond to the
48-week pegylated interferon-ribavirin treatment standard.
In studies of HCV infected individuals, treatment with the Hemopurifier®
resulted in robust viral load reductions in HCV patients who completed a
treatment protocol of three, 4-hour Hemopurifier® treatments every other
day during the course of one week. The study was conducted at the Fortis
Hospital in Delhi, India.
Patient #1 had a 95% reduction three days post treatment and 89%
reduction seven days post treatment. The initial viral load for patient
1 was 5.3 x 10(5) viral units per ml of blood (IU/ml). Patient 1’s viral
load seven days post treatment was 5.7 x 10(4) IU/ml.
Patient #2 had an 85% reduction three days post treatment and 50%
reduction seven days post treatment. The initial viral load for patient
2 was 9.2 x 10(6) IU/ml. Patient 2’s viral load seven days post
treatment was 4.6 x 10(6) IU/ml.
Patient #3 had a 60% reduction three days post treatment and 83%
reduction seven days post treatment. The initial viral load for patient
3 was 3.0 x 10(8) IU/ml. Patient 3’s viral load seven days post
treatment was 5.1 x 10(7) IU/ml.
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®, 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® also holds promise in cancer care,
as research studies verify the Hemopurifier® effectively captures
immunosuppressive exosomes that are secreted by tumors to kill-off
immune cells. At present, over sixty-five (65) Hemopurifier® 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® is effective
in capturing a broad-spectrum of viruses untreatable with drug therapy,
including several of the 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® technology platform to establish
a pipeline of clinical and research diagnostic products and services.
Additional information regarding Aethlon Medical can be accessed 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
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.
Source: Aethlon Medical, Inc.
Aethlon Medical, Inc.Prashant Mehta, Ph.D.Director of
Business Development858-459-7800 x303pmehta@aethlonmedical.comorJim
FrakesSenior VP Finance858-459-7800 x300jfrakes@aethlonmedical.comorJim
JoyceChairman, CEO858-459-7800 x301jj@aethlonmedi
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