SAN DIEGO, May 8, 2012 /PRNewswire/ -- Aethlon Medical,
Inc. (OTCBB: AEMD), the pioneer in developing selective
therapeutic filtration devices to address infectious disease,
cancer and other life-threatening conditions, reported today that
the presence of Hepatitis C virus (HCV) is currently undetectable
in all infected patients that have been treated with the Aethlon
Hemopurifier® in combination with peginterferon+ribavirin (PR) drug
therapy and monitored for at least ninety days.
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In a study conducted at the Medanta Medicity Institute
(Medicity), HCV-infected individuals were enrolled to receive up to
three, six-hour Hemopurifier® treatments during the first three
days of PR drug therapy. The Medicity is a $360 million multi-specialty medical institute
established to be a premier center for medical tourism in
India. The Aethlon Hemopurifier® is a first-in-class medical
device that selectively targets the rapid clearance of HCV from the
entire circulatory system to improve benefit, dose, duration and
tolerability of drug therapies.
In the Medicity study, Aethlon reported that Hemopurifier®
therapy has been well tolerated and without device-related adverse
events in nine treated patients. Of these nine patients, six
patients were infected with HCV genotype-1; two patients were
infected with HCV genotype-3; and one patient was infected with HCV
genotype-5. Of the nine reported patients, seven have been
monitored for more than ninety days. All seven currently
maintain undetectable viral load, including three patients who have
been monitored for 48-weeks. Two patients initiated
Hemopurifier® therapy on April 18th
and April 30th, and therefore have
not yet been monitored for extended viral load suppression.
The Immediate Impact of Hemopurifier® Therapy
In addition to demonstrating safety and early efficacy against
multiple HCV genotypes, a clinical objective of the Medicity study
was to evaluate whether the Hemopurifier® could accelerate HCV
eradication to levels associated with treated patients who achieve
the highest rate of viral cure, including individuals that
previously failed or relapsed PR drug regimens. In the study,
Aethlon observed that viral load depletion during the Hemopurifier®
+ PR drug therapy phase was greatest in hard-to-treat genotype-1
patients with high viral load. In one treated patient,
baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when
measured after the third day of Hemopurifier® + PR therapy,
representing a 3.49 log or 99.96% reduction of viral load. In
another patient, baseline HCV RNA dropped from 8,760,000 IU/ml to
4,665 IU/ml when measured on day-3, representing a 3.27 log or
99.96% reduction. By contrast, a moderate viral load
Hemopurifier® patient with baseline HCV RNA of 1,340,000 IU/ml
dropped to 54,900 IU/ml when measured on day-3, representing a 1.38
log or 95.9% reduction.
As a point of reference, the landmark IDEAL Study of 3,070 HCV
genotype-1 patients documented that less than 5% of treated
patients will achieve a 2-log or greater reduction of viral load
when measured 7-days after the start of PR drug therapy.
While the IDEAL study did not report day-3 viral load, a 2-log+
reduction at day-7 is a rare occurrence defined as an immediate
virologic response (IVR). The IDEAL study confirms the viral cure
or sustained virologic response rate of IVR patients to be greater
than 90%. Based on Medicity treatment outcomes, Hemopurifier®
therapy had a significant impact in accelerating HCV eradication in
high viral load patients.
Capacity of the Hemopurifier® to Capture HCV During
Treatment
As the result of discussions with reviewers at the Center for
Devices and Radiological Health (the FDA branch responsible for
approving medical devices in the US), Aethlon recently expanded the
Medicity protocol to establish a data point that would quantify the
amount of HCV captured within the Hemopurifier® during a single
treatment. In one analyzed cartridge, researchers recovered
and measured that approximately 300 billion (300,000,000,000)
copies of HCV had been captured within the Hemopurifier® during a
single six-hour treatment at the Medicity. Beyond the impact
of inhibiting progeny virus replication, the viral capture data
point defines the contribution Hemopurifier® therapy can provide to
current and future antiviral drug treatment regimens. Aethlon
considers this data point to be unprecedented as the previous
ability to measure the benefit of HCV therapies has primarily been
limited to measuring changes in the amount of virus that can be
detected in circulation.
Next Steps
As a result of Hemopurifier® + PR therapy outcomes, Aethlon has
requested permission from the Medicity internal review board (IRB)
to begin offering Hemopurifier® therapy to HCV-infected individuals
that reside outside of India. The Company has also requested
IRB permission to expand the treatment protocol to allow for up to
seven Hemopurifier® treatments to be administered during the first
week of PR drug therapy. Based on previous three-treatment
protocol outcomes, Aethlon anticipates an expanded Hemopurifier®
dosing schedule could establish new milestones for early
undetectable viral load achievement. The Company also disclosed it
will resubmit an investigational device exemption (IDE) which
incorporates the Medicity data as part of its effort to gain FDA
approval to initiate clinical programs in the U.S.
It is estimated that approximately 4 million Americans and 170
million people worldwide are infected with HCV, which leads to
chronic liver disease or cirrhosis, and is the leading cause of
liver transplant in the U.S. To date, almost 100
Hemopurifier® treatments have been administered in human studies.
Previously, studies of the Hemopurifier® have been conducted at the
Apollo, Fortis, and Sigma New Life hospitals in India. These studies demonstrated that
Hemopurifier® therapy could safely reduce viral load in both HIV
and HCV-infected dialysis patients without the administration of
antiviral drug therapies. The Medicity study represents the
first Hemopurifier® study in non-dialysis patients. In vitro
studies have further validated the ability of the Hemopurifier® to
capture a broad-spectrum of viral pathogens classified as bioterror
or pandemic threats.
About Aethlon Medical
The Aethlon Medical mission is to create innovative medical
devices that address unmet medical needs in cancer, infectious
disease, and other life-threatening conditions. Our Aethlon ADAPT™
System is a revenue-stage technology platform that provides the
basis for a new class of therapeutics that target the selective
removal of disease enabling particles from the entire circulatory
system. The Aethlon ADAPT™ product pipeline includes the Aethlon
Hemopurifier® to address infectious disease and cancer; HER2osome™
to target HER2+ breast cancer, and a medical device being developed
under a contract with DARPA that would reduce the incidence of
sepsis in combat-injured soldiers and civilians. For more
information, please visit www.aethlonmedical.com.
Certain 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, that the FDA
will not approve the initiation of the Company's clinical programs
or provide market clearance of the company's products, future human
studies of the Aethlon ADAPT™ system or the Aethlon Hemopurifier®
as an adjunct therapy to improve patient responsiveness to
established cancer therapies, the Company's ability to raise
capital when needed, the Company's ability to complete the
development of its planned products, the Company's ability to
manufacture its products either internally or through outside
companies 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. These statements, including
patient data, are based on information currently available to the
Company's management and future patient results may differ from
present results. The Company undertakes no obligation
to publicly update or revise any forward-looking statements,
whether as a result of new information, future events, or
otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
SOURCE Aethlon Medical, Inc.