SAN DIEGO - June 25, 2013 (Investorideas.com newswire) - Aethlon Medical, Inc. (
OTCQB: AEMD),
announced today that the United States Food and Drug Administration
(FDA) has approved an Investigational Device Exemption (IDE) that allows
the Company to initiate human feasibility studies of the Aethlon
Hemopurifier® in the United States. The Hemopurifier® is a
first-in-class medical device that targets the rapid elimination of
life-threatening infectious disease and cancer glycopathogens from
circulation.
Under the feasibility study protocol, Aethlon will enroll ten end
stage renal disease (ESRD) patients who are infected with the Hepatitis C
virus (HCV) to demonstrate the safety of Hemopurifier therapy .
Successful completion of the feasibility study will set the stage for
Aethlon to conduct pivotal studies required for market clearance to
treat HCV and potentially other disease conditions.
"Obtaining FDA's permission to initiate human studies has been our
most important objective for several years," stated Jim Joyce, Chairman
and CEO of Aethlon Medical. "I salute the perseverance of our dedicated
Aethlon team, their families, and loyal shareholders whose support
allowed us to endure the challenges of navigating through FDA. We plan
to reward your faith with clinical execution and progression toward a
marketable therapy in the United States."
Specific to the treatment of HCV, the Hemopurifier is uniquely
positioned as an adjuvant to be incorporated with either
interferon-based standard of care (SOC) or emerging all-antiviral drug
regimens without adding drug toxicity. In addition to augmenting the
early viral kinetic response to SOC, the Hemopurifier is a candidate
solution for viral rebound patients who traditionally are forced to
discontinue therapy at the point HCV establishes resistance to drug
regimens. Additionally, the Hemopurifier addresses the large population
of HCV-infected ESRD patients for which SOC and emerging all-antiviral
strategies may be contraindicated or not yet cleared. According to the
World Health Organization (WHO), HCV is a blood-borne pathogen that
affects upwards of 170 million persons, or 2-3% of the world's
population. It is a leading cause of cirrhosis and liver
transplantation.
The FDA approved Hemopurifier therapy feasibility study calls for a
single-site enrollment of ten HCV-infected end-stage renal disease
(ESRD) patients who have not received any pharmaceutical therapy for
their HCV infection for at least 30 days. The protocol consists of a
control phase which consists of three consecutive standard dialysis
treatments during week one followed by the inclusion of the Hemopurifier
during a total of six dialysis sessions conducted during weeks two and
three. The rate of adverse events observed during the Hemopurifier
therapy phase will be compared to the rate experienced during the
control phase. Per-treatment changes of viral load will be observed
through quantitative PCR analysis. Additionally, Aethlon may also choose
to quantitate HCV viral copies captured within the Hemopurifier during
each treatment session.
In studies previously conducted in India, Hemopurifier therapy was
demonstrated to be well tolerated in treatment naïve HIV and
HCV-infected ESRD patients when included during normally scheduled
four-hour dialysis sessions. In these studies, average per treatment
viral load reductions were observed to exceed 50% in both disease
conditions. In follow-on studies of non-ESRD individuals infected with
HCV, a three-treatment protocol of Hemopurifier therapy in combination
with interferon-based standard of care (SOC) resulted in undetectable
HCV in as little as seven days in hardest to treat genotype-1 patients.
The studies also documented the ability of the Hemopurifier to capture
as many as 300 billion HCV copies during a single six-hour treatment.
"Aethlon Medical has been laying the groundwork necessary to
implement the now approved clinical trial protocol for several years"
said Rod Kenley, Aethlon's President. "We are finally able to move
forward with our contract research and clinical partners in finalizing
all of the activities that can now take place prior to initiating
treatment of the first patient. While there is still some work to be
done, today the biggest hurdle has been cleared and we are anxious to
make rapid
progress towards commercialization."
The feasibility study protocol was originally designed as a human
safety challenge and model for addressing drug and vaccine resistant
bioterror and emerging pandemic threats such as the Middle East
Respiratory Syndrome (MERS) now spreading overseas.
In vitro
studies conducted by leading government and non-government researchers
have demonstrated that the Hemopurifier is able to capture a
broad-spectrum of some of world's deadliest viral pathogens. These
include: Dengue hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF),
Lassa hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), H1N1
swine flu virus, the reconstructed 1918 influenza virus (r1918), West
Nile virus (WNV) and Vaccinia and Monkeypox (MPV), which serve as models
for human smallpox infection. Human efficacy studies are not
permissible against high-threat bioterror and pandemic threats.
The Hemopurifier is also being tested for its ability to capture
glycopathogen targets that initiate or enhance the progression of sepsis
through a contract with the Defense Advanced Research Projects Agency
(DARPA). Sepsis is a life-threatening illness triggered by an
overwhelming infection of the bloodstream. Globally, there are 18
million cases of diagnosed sepsis per year and the incidence is rising
at 8 to 10% annually.
In cancer, the Hemopurifier has been discovered to capture
tumor-derived exosomes underlying several forms of cancer.
Tumor-derived exosomes have recently emerged to be a vital therapeutic
target in cancer care. These microvesicular particles suppress the
immune response in cancer patients through apoptosis of immune cells and
their quantity in circulation correlates directly with disease
progression. Beyond possessing immunosuppressive properties,
tumor-derived exosomes facilitate tumor growth, metastasis, and the
development of drug resistance. By addressing this unmet medical need,
the Hemopurifier is positioned as an adjunct to improve established
cancer treatment regimens. I
n vitro studies to date have also
documented that the Hemopurifier captures exosomes underlying lymphoma,
melanoma, ovarian, and breast cancer.
In design, the Aethlon Hemopurifier consists of the affinity lectin
Galanthus nivalis agglutinin (GNA) immobilized in the outer-capillary
space of advanced plasma membrane technology. The design allows for
extracorporeal therapeutic delivery to occur on standard CRRT and
dialysis instruments already located in hospitals and clinics worldwide.
The mechanism of the Hemopurifier to rapidly eliminate a broad-spectrum
disease targets is based on GNA's ability to selectively bind unique
high mannose signatures that are abundant on the surface of
cancer-secreted exosomes and glycoproteins that reside on the outer
membrane of infectious viral pathogens.
The Company will continue to update shareholders, constituents and
potential study participants as feasibility study milestones are
achieved, including naming a principal investigator, initiation of
patient enrollment and the beginning of treatments with the Aethlon
Hemopurifier.
About Aethlon Medical
Aethlon Medical creates 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 devices the rapid, yet selective removal of disease promoting
particles from the entire circulatory system. At present, The Aethlon
ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address
infectious disease and cancer, and a medical device being developed
under a 5-year contract with Defense Advanced Research Projects Agency
(DARPA) to reduce the incidence of sepsis in combat-injured soldiers.
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 company can successfully protect its intellectual
property, that removal of exosomes from the human body will impact or
lead to successful treatment of cancer, or that exosomes are the cause
of tumor growth and progression, 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, 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. 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.
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