Medical Technology Breaking News: Aethlon Medical (OTCBB:
AEMD) Reports Rapid and Sustained Virologic Response Rates in Hepatitis C (HCV)
Treated Patients
SAN DIEGO - December 2, 2014 (Investorideas.com newswire)
Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing targeted therapeutic
devices to address infectious disease and cancer, today reported final clinical
outcomes, including rapid virologic response (RVR) and sustained virologic
response (SVR) rates, in Hepatitis-C virus (HCV) infected individuals who
received Hemopurifier® therapy during a clinical study conducted at the Medanta
Medicity Institute in India. Aethlon is now preparing to launch its first human
clinical studies in the United States.
The
Aethlon Hemopurifier® is a first-in-class bio-filtration device that targets
the rapid elimination of viruses and immunosuppressive proteins from the
circulatory system of infected individuals. The device is a leading
broad-spectrum treatment countermeasure against viral pathogens that are not
treatable with drug or vaccine therapies. In HCV care, the device is positioned
to address antiviral drug resistance and hard-to-treat patients who are unable
to tolerate normally administered doses of antiviral drugs or
peginterferon+ribavirin (PR) therapy. 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.
In
addition to reporting RVR and SVR rates, Aethlon disclosed that it achieved the
following clinical objectives of the HCV study:
·
To
demonstrate that Hemopurifier® therapy could be administered safely in
non-dialysis patients who were infected with HCV.
·
To
demonstrate the ability to combine Hemopurifier® therapy with an established
therapeutic drug regimen.
·
To
demonstrate that the brief inclusion of Hemopurifier® therapy can improve the
normally expected benefit of a therapeutic drug regimen.
·
To
establish an elution protocol that allows researchers to quantify the number of
viruses captured within the Hemopurifier® during a single treatment.
In the
study, HCV-infected individuals were enrolled to receive three six-hour
Hemopurifier® treatments during the first three days of a 48-week
peginterferon+ribavirin (PR) treatment regimen. The study was conducted under
the leadership of Dr. Vijay Kher at the Medanta Medicity, a multi-specialty
medical institute established to be a premier center for medical tourism in
India. Aethlon reported that Hemopurifier® therapy was well tolerated and
without device-related adverse events in twelve treated patients. Of these
twelve patients, ten completed the Hemopurifier-PR treatment protocol,
including eight genotype-1 patients and two genotype-3 patients. Eight of the
ten patients (n=8/10) achieved a sustained virologic response (SVR), which is
the clinical definition of treatment cure and is defined as undetectable HCV
RNA 24-weeks after the completion of the 48-week PR drug regimen. Both
genotype-3 patients achieved a SVR (n=2/2), while six of the eight genotype-1
patients achieved a SVR (n=6/8).
Of the
ten patients that completed the full treatment protocol, five (n=5/10) also
achieved a rapid virologic response (RVR), defined as undetectable HCV RNA at
day 30 of therapy. RVR represents the clinical endpoint that best predicts SVR
cure rates resulting from PR therapy.
As a
point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients
documented that 10.35% (n=318/3070) of PR treated patients achieved a RVR.
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. Aethlon also disclosed that two
of the genotype-1 patients who achieved a RVR also achieved an immediate
virologic response (IVR), defined as undetectable HCV RNA seven days after
initiation of Hemopurifier-PR treatment protocol. The incidence of IVR was not
reported in the IDEAL study.
Data from
two patients was not included in the reported Hemopurifier-PR dataset. One of
these patients was a genotype-5 patient who discontinued PR therapy at day 180,
yet still achieved a SVR. The second patient was a genotype-3 patient who also
achieved a SVR, yet was unable to tolerate PR therapy and discontinued therapy
at day-90. Overall, ten of the twelve patients (n=10/12) who enrolled in the
study achieved a SVR and seven of the twelve (n=7/12) patients achieved an RVR.
Aethlon
further disclosed that it established an elution protocol during the study that
allowed researchers to quantify the number of viruses captured within the
Hemopurifier® during a single treatment. As a result, researchers were able the
measure that as many as 300 billion copies of HCV had been captured during a
single six-hour treatment.
Aethlon
is now preparing to launch the first U.S. clinical Hemopurifier® based on the
United States Food and Drug Administration's (FDA)'s approval of an
Investigational Device Exemption (IDE). The study, which will be conducted at
the DaVita MedCenter Dialysis in Houston, Texas, will contribute safety data to
support the advancement of Hemopurifier® therapy as a broad-spectrum
countermeasure against bioterror and pandemic threats and chronic viral
pathogens such as HIV and HCV. Hemopurifier® therapy is available to treat
Ebola patients in the U.S. through FDA expanded access "emergency
use" provisions to address life threatening circumstances for which an
alternative therapy is not available. At present, no antiviral therapy or
vaccine has proven to be effective against Ebola virus infection in humans.
About Aethlon Medical, Inc.
Aethlon
Medical creates targeted therapeutic devices to address infectious disease,
cancer and neurodegenerative disorders. The company's lead product is the Aethlon
Hemopurifier®, a first-in-class antiviral and immunotherapeutic device that
selectively targets the broad-spectrum elimination of circulating viruses and
tumor-secreted exosomes that promote cancer progression. Exosome Sciences, Inc.
is a majority owned subsidiary that is advancing exosome-based products to
diagnose and monitor cancer, infectious disease and neurological disorders. For
more information, please visit http://www.aethlonmedical.com and connect with
the Company on Twitter, LinkedIn,
Facebook and Google+.
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 ESI will not be able to
commercialize its future products, 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 whether revenue or non-revenue generating of the
Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to
improve patient responsiveness to established cancer or hepatitis C therapies
or as a standalone cancer or hepatitis C therapy or as a broad spectrum defense
against viral pathogens, including ebola, 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, the ability of the Company to meet the milestones contemplated in
the DARPA contract, 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. 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:
Sign up
for the free investor news and stock alerts:
Disclaimer/Disclosure: The Investorideas.com newswire is a third party
publisher of news and research as well as creates original content as a news
source. Original content created by investorideas is protected by copyright
laws other than syndication rights. Investorideas is a news source on Google
news and Linkedintoday plus hundreds of syndication partners. Our site does not
make recommendations for purchases or sale of stocks or products. Nothing on
our sites should be construed as an offer or solicitation to buy or sell
products or securities. All investment involves risk and possible loss of
investment. This site is currently compensated by featured companies, news
submissions, content marketing and online advertising. Contact each company
directly for press release questions. Disclosure is posted on each release if
required but otherwise the news was not compensated for and is published for
the sole interest of our readers. More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp
Disclosure:
AEMD subscribes to the Investorideas newswire content publishing annual program
(9700 per Year, paid quarterly) for news publishing.
BC
Residents and Investor Disclaimer: Effective September 15 2008 - all BC
investors should review all OTC and Pink sheet listed companies for adherence
in new disclosure filings and filing appropriate documents with Sedar. Read for
more info: http://www.bcsc.bc.ca/release.aspx?id=6894. Global investors
must adhere to regulations of each country.
Become an Investorideas.com Member and access our 14 online stock
directories 24/7 –biotech, defense, mining stocks, oil and gas stocks and
more...
