SAN DIEGO - February 5, 2013 (Investorideas.com newswire) - Aethlon Medical, Inc. (
OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
In our quest to innovate life-saving therapeutics, we have
persevered through untold challenges to create a single medical device
that offers to optimize the benefit of cancer and infectious disease
therapies. As our endeavors transitioned beyond R&D, we thought we
were cognizant of the entire alphabet soup of healthcare and financial
regulatory agencies we would need to navigate to bring our technology to
market.
However, on September 30th 2011, we were blindsided by an action
never anticipated. The Depository Trust Company (DTC) eliminated the
electronic transfer of our securities, otherwise known as a "DTC Chill."
As a result, broker-dealers across America began to restrict or
prohibit trading in Aethlon Medical shares, which in turn reduced
liquidity and inhibited the true sentiment for our company to be
accurately reflected by the public markets. A recently published
viewpoint of a securities law firm provides a more succinct perspective
on a DTC Chill:
"The Depository Trust Company is the only stock depository in the
U.S. When DTC provides services as the depository for an issuer's
securities, its securities can trade electronically. Without DTC
eligibility, it is almost impossible for an issuer to establish an
active market in its securities."
As the result of protracted legal effort, DTC has agreed to lift
the restriction on the electronic transfer of our securities, which we
reported in an SEC filing on January 7th. In a related event, I am
pleased to inform shareholders and other interested parties that our
transfer agent has notified us that the CUSIP underlying our shares is
now unlocked to again allow for our shares to be electronically traded
on the DTC system. Thus, signaling the end of a lengthy and
disheartening challenge faced by our organization.
While we cannot measure the full impact the DTC Chill, I ask you to
consider some of our milestone achievements since September 30th, 2011.
Milestone achievements that many biotechnology or medical device
organizations would envy.
On the day (yes, the exact same day) the DTC Chill went into
effect, we transitioned from a development-stage to revenue-stage
organization as the result of a $6.8 Department of Defense (DOD)
contract award from the Defense Advanced Research Projects Agency
(DARPA). Since contract initiation, we have generated in excess of $2
million in revenues and have advanced the development of a device and
blood processing system to combat sepsis.
Related to our DARPA program, we teamed with two larger industry
organizations to respond to a $25 million systems integrator contract
opportunity. The recipient of this contract has not yet been announced
by DARPA.
We reported our first Hepatitis-C (HCV) efficacy
data
related to the use of our Hemopurifier® as an adjunct to optimize the
benefit of standard of care drug therapy. The results exceeded
expectations as a three-treatment Hemopurifier® protocol was
demonstrated to reduce viral load to undetectable levels in as little as
seven days. Since September 30th, 2011, organizations with clinical
stage adjunct therapies have been acquired for a much as $11 Billion.
Based on prior discussions with the U.S. Food and Drug
Administration (FDA), we established a protocol to elute the
post-treatment biological fluid from the Hemopurifier® as a means to
quantify HCV capture. The result established an unprecedented data
point validating the capture of up to 300 billion copies of HCV during a
single treatment. I plan to detail the relevance of this datapoint in a
future CEO note.
As the result of our HCV treatment outcomes, the Medanta Medicity
Institute is now offering Hemopurifier® therapy on a compassionate-use
basis to HCV-infected individuals.
We submitted an Investigational Device Exemption (IDE) to the FDA
to request permission to initiate a clinical feasibility study HCV
infected individuals who would be enrolled to receive Hemopurifier®
therapy. We have since received comments and study design
considerations back from FDA and are preparing a response that we hope
will lead to the initiation of U.S. clinical studies.
Since September 30th, 2011, we advanced studies that validated the
ability of our Hemopurifier® to capture exosomes underlying different
forms of cancer. Tumor-secreted exosomes have been discovered to play a
vital role in cancer progression and it has recently become clear that a
successful war against cancer will need to address these particles.
Our Hemopurifier® is the first therapeutic candidate to address
tumor-secreted exosomes.
We expanded our intellectual property portfolio of pending and
issued patents. As the result of our early exosome research, we were
recently issued a patent that protects our cancer treatment strategy in
the United States for the next two decades.
We disclosed that researchers at the Morehouse School of Medicine
discovered that the Hemopurifier® captures HIV exosomes, which transport
NEF protein to assist HIV in maintaining the suppression of the immune
system, even when antiviral drugs are able to achieve undetectable viral
load in treated patients.
We began shipping our exosome assay (ELLSA), which we originally
created to support our own research, to researchers who are utilizing
its capabilities to create new diagnostic tools that have the potential
to identify a variety of disease conditions in blood and urine.
We received the support of highly regarded thought leaders from the
extracorporeal, sepsis, and cancer field who agreed to join our science
advisory board.
We believe that these selected achievements portray a company that
is making significant progress despite the challenges of being a small
public company that was saddled with a DTC Chill since September 30th,
2011.
In closing, I am forever grateful to those shareholders that have
loyally supported our endeavors even in the darkest moments. Your belief
validates many sacrifices and inspires the strength to continue waging
every fight necessary to ensure our innovation has the opportunity to
save lives.
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.
About The Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device that
selectively targets the rapid clearance of infectious viral pathogens
and immunosuppressive proteins from the entire circulatory system. In
the treatment of Hepatitis C virus (HCV), human studies have
demonstrated that Hemopurifier® therapy may improve immediate, rapid and
sustained virologic response rates when administered in the first few
days of standard-of-care drug therapy. In addition to accelerating viral
load depletion, post-treatment analysis of the Hemopurifier® has
documented the capture of up to 300 billion HCV copies of HCV during a
single six-hour treatment. Access to Hemopurifier® therapy is available
on a compassionate-use basis through the Medanta Medicity Institute
(Medicity), a leading center for medical tourism in India. The Medicity
is offering treatment access to infected individuals who previously
failed or subsequently relapsed standard-of-care drug regimens. The
Hemopurifier® is also being offered as a salvage therapy to infected
individuals who suffer a viral breakthrough during standard-of-care
therapy. U.S. studies of the Hemopurifier® are currently pending
approval of an IDE submitted to FDA.
The Aethlon Hemopurifier® and Cancer
In addition to the opportunity to address a broad-spectrum of
infectious viral pathogens, 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.
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.
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
Published at Investorideas.com Newswire
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