SAN DIEGO - May 8, 2012 (Investorideas.com newswire) - 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.
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 the Defense
Advanced Research
Projects Agency (DARPA) that would reduce the incidence of sepsis in
combat-injured soldiers and civilians. For more information, please
visit
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 ability for the Company
to derive
business
partnerships or future revenue streams using the Aethlon ADAPT™ system
including the ability to introduce a targeted breast cancer therapy
known as HER2osome™, there is no assurance that FDA will approve the
initiation of the company's clinical programs or provide market
clearance of the company's products, the ability to achieve the goals
set out in the DARPA contract, future human studies of 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.
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
John P. Salvador
Director,
Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
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