Aethlon Medical Releases Shareholder Letter
December 08 2009 - 8:00AM
PR Newswire (US)
SAN DIEGO, Dec. 8 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc.,
(OTC Bulletin Board: AEMD) disclosed today that its Chairman and
CEO, James A. Joyce has issued the following letter to
shareholders. (Logo:
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b) To our
Shareholders: In my September 15th shareholder letter, I indicated
that we initiated the program with Bioserv/NextPharma to produce
our Hemopurifier® under good manufacturing practice (GMP)
requirements set forth in quality system (QS) regulations for
medical device commercialization. Today, I am pleased to report
that we have now established our GMP manufacturing processes.
Furthermore, we kicked-off our inaugural production run yesterday,
which should allow us to commence with our first Hemopurifier®
shipments in February. The task of establishing manufacturing of
our Hemopurifier® under GMP was an intricate process requiring
significant expertise and a focused commitment among many
participants. I applaud the tireless efforts of Dr. Richard Tullis,
Paul Duffin, and our colleagues at Bioserv/NextPharma. The initial
commercialization of our Hemopurifier® remains focused towards
treating individuals infected with Hepatitis-C virus (HCV) at
select medical centers in India. At present, fewer than half of
HCV-infected individuals who initiate the 48-week
interferon-ribavirin standard of care (SOC) drug regimen
successfully respond to treatment. With an estimated 180 million
people infected worldwide, a monumental need exists for adjunct
therapies that can improve HCV cure rates without increasing the
considerable toxicity already associated with SOC therapy. In this
regard, we have established a data-supported strategy that provides
an opportunity to play a central and enduring role in HCV care. Our
strategy uniquely positions our Hemopurifier® to enhance the
benefit of SOC therapy even if the drug combinations underlying SOC
become redefined. While our Hemopurifier® is the first-in-class
device to selectively capture viruses and immunosuppressive
proteins from circulation, the precedent for a device to treat HCV
was established by Asahi Kasei Kuraray Medical (Asahi), who
validated that moderate levels of viral filtration at the outset of
SOC therapy improves cure rates. Asahi demonstrated that their
multi-cartridge approach, which is marketed in Japan as V-RAD, was
able to achieve 71.4% cure rates in HCV patients who previously
failed SOC therapy. In Asahi's studies, V-RAD was administered once
daily for three consecutive days at the outset of SOC therapy and
provided an average viral load reduction of 26.1% during each
treatment period, which averaged 3 1/4 hours in duration.
Amazingly, such outcomes were achieved without a further need for
viral filtration during the remaining 47+ weeks of SOC therapy. On
October 30th, we reported HCV treatment outcomes at the 42nd Annual
American Society of Nephrology (ASN) Conference. When analyzing
Hemopurifier® treatment data from all of our HCV human studies, we
documented average per-treatment viral load reductions of 29-42%.
While the length of each Hemopurifier® treatment was similar in
duration to V-RAD, the Hemopurifier® did not benefit from SOC
associated viral load reductions as our results were achieved in
the absence of SOC therapy. We acknowledge and appreciate that
V-RAD has indeed documented that viral filtration improves HCV
treatment outcomes. However, we believe the Hemopurifier® delivers
the necessary capabilities to establish broad-market acceptance of
medical device in infectious disease care. Foremost of these
capabilities is our ability to selectively capture infectious
viruses and immunosuppressive proteins not addressed by V-RAD. The
selective capture of deleterious agents from circulation
establishes an environment that permits continuous or aggressive
intermittent treatment strategies that can truly optimize patient
outcomes. Whereas historic therapeutic filtration approaches,
including V-RAD, are restricted in scope as they indiscriminately
remove particles from blood by molecule size. As a result, the safe
application of such treatments remains limited as beneficial blood
components required for health are removed along with the
deleterious target. In the face of a challenging economic climate,
we have reached a pivotal stage that positions us to capitalize on
the sum of our efforts during the last decade. We have not deviated
in our vision to evolve what once existed as a theoretical concept
into the reality of a device that could change the lives of those
afflicted with HCV and other infectious disease conditions. On
behalf of our dedicated team at Aethlon Medical, I thank you for
your continued support. Very truly yours, James A. Joyce Chairman,
CEO Certain of the statements within this shareholder letter 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 capability of the Hemopurifier® to reduce viral
loads and other disease conditions, the Company's ability to raise
capital when needed, the Company's ability to complete the
development of its planned products, the ability of the Company to
obtain FDA and other regulatory approvals permitting the sale of
its products, the Company's ability to manufacture its products 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: Jon
Cunningham RedChip Companies Inc. (407) 644-4256 (407) 491-4498
-cell or Jim Joyce Chairman, CEO 858.459.7800 x301 Jim Frakes
Senior VP Finance 858.459.7800 x300
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b
http://photoarchive.ap.org/ DATASOURCE: Aethlon Medical, Inc.
CONTACT: Jon Cunningham, RedChip Companies Inc., +1-407-644-4256,
Cell, +1-407-491-4498, or ; Jim Joyce, Chairman, CEO,
+1-858-459-7800, ext. 301, , Jim Frakes, Senior VP Finance,
+1-858-459-7800, ext. 300, , both of Aethlon Medical, Inc. Web
Site: http://www.aethlonmedical.com/
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