SAN DIEGO - August 9, 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, announced today that it has agreed to establish a treatment
program that will provide HCV-infected individuals with expanded access
to Hemopurifier® therapy. The program is being initiated with support
from the Institutional Review Board at the Medanta Medicity Institute
(Medicity) to allow compassionate usage of the Aethlon Hemopurifier® for
individuals who previously failed or subsequently relapsed
standard-of-care drug regimens.
In addition to offering Hemopurifier® therapy to the citizens of
India, HCV-infected individuals from the United States, European Union
and other regions of the world may pursue treatment through the expanded
access program. Details related to treatment protocol, inclusion
criteria, patient approval processes and therapy pricing are anticipated
in September. It is estimated that approximately 170 million people
worldwide are infected with HCV, which leads to chronic liver disease or
cirrhosis, and is a leading cause of liver transplantation.
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. The Medicity is a $360 million multi-specialty
medical institute established to be a premier center for medical tourism
in India.
"The Medicity access program represents an important milestone in
our quest to establish the selective therapeutic filtration industry,"
stated Aethlon Chairman and CEO, Jim Joyce. "Beyond helping
HCV-infected individuals overcome their disease, we now have the
opportunity to augment our established government contract revenues with
Hemopurifier® product sales."
Aethlon also disclosed that it will continue conducting a study at
the Medicity that is evaluating the capability of the Aethlon
Hemopurifier® to accelerate HCV RNA depletion at the outset of standard
of care peginterferon+ribavirin (PR) therapy. Specifically,
HCV-infected individuals are enrolled to receive up to three, six-hour
Hemopurifier® treatments during the first three days of PR drug therapy.
Last week, Aethlon reported that the two most recent HCV infected
patients to receive Hemopurifier® therapy in combination with PR drug
therapy achieved undetectable viral load at day-7, which is rarely
reported in drug therapy alone.
The primary clinical endpoint of the Medicity protocol has been to
increase the incidence of rapid virologic response (RVR), defined as
undetectable HCV RNA at day 30 of therapy. RVR represents the clinical
endpoint that best predicts treatment cure, otherwise known as sustained
virologic response (SVR), defined as undetectable HCV RNA 24-weeks
after the completion of PR drug therapy. As a point of reference, the
landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that
only 10.35% (n=318/3070) of PR treated patients achieved a RVR.
However, patients that achieved a RVR had SVR rates of 86.2% (n=274/318)
versus SVR rates of 32.5% (n=897/2752) in non-RVR patients. While the
incidence of undetectable HCV RNA at day-7 is not reported in the IDEAL
study, the study did reveal that just 4.3% (n=131/3070) of patients
achieved undetectable HCV RNA at day-14, which equated to a 91%
(n=118/131) SVR rate.
Aethlon reported that Hemopurifier® therapy has been well tolerated
and without device-related adverse events in ten treated patients. Of
these ten patients, seven patients were infected with HCV genotype-1;
two patients were infected with HCV genotype-3; and one patient was
infected with HCV genotype-5. At present, undetectable HCV RNA is
reported in eight of the 10 treated patients. Of the two patients with
detectable HCV RNA, one discontinued PR therapy as a result of a
diabetes related condition. HCV RNA is undetectable in all patients
(n=4) that have been monitored for 48 weeks since receiving
Hemopurifier® therapy. Among the 10 treated patients, Aethlon reported
that six genotype-1 patients received the three treatment Hemopurifier®
protocol, which resulted in four (67%) patients achieving a RVR. The
IDEAL study predicts it would normally require approximately 40 PR
treated patients to achieve 4 RVR outcomes. Both patients who achieved
undetectable HCV RNA at day-7 also achieved a RVR. Beyond the high
likelihood of a SVR, genotype-1 patients that achieve a RVR also have
the opportunity to reduce the duration of PR drug therapy from 48 weeks
to 24 weeks.
In addition to expanding access to Hemopurifier® therapy at the
Medicity, Aethlon is preparing to resubmit to the FDA an investigational
device exemption (IDE), which will incorporate the Medicity data in an
effort to gain approval to initiate HCV clinical programs in the United
States.
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
Marc Robins
877.276.2467
mr@aethlonmedical.com
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