Medical Technology Breaking News: Aethlon Medical (OTCQB:
AEMD) CEO Note: A Novel Strategy To Address Ebola
SAN DIEGO - August 6, 2014 (Investorideas.com newswire) Aethlon
Medical, Inc. (OTCBB:AEMD),
today released the following note authored by its Chairman and CEO, Jim Joyce.
The
current ebola outbreak in West Africa demonstrates the urgent need for
therapeutic strategies to defend against emerging pandemic threats. It also
highlights why the Department of Health and Human Services (HHS) has shifted
the focus of government biodefense and pandemic threat initiatives toward
broad-spectrum therapies able to target multiple pathogens. At present, a
majority of all infectious viruses are not addressed by drug therapies, which
are designed to inhibit or block replication of a single viral species.
At Aethlon Medical, we are intersecting
advanced biology with modern plasma membrane technology to rethink the
treatment of viral pathogens. The result is the Aethlon Hemopurifier®, a
therapeutic device that has been validated to capture a broad-spectrum of viral
pathogens and immunosuppressive proteins through affinity binding to a unique
high-mannose structure that is co-opted from the host (the infected individual)
as a means for viruses to evade detection of the host immune system. We have
also discovered that this signature exists on tumor-secreted exosomes that
promote cancer progression.
We believe our Hemopurifier® is the most
advanced and perhaps only true broad-spectrum countermeasure against emerging
pandemic threats such as ebola, and viral threats that could be weaponized to
purposely infect civilian and military populations. Our belief is supported by
human clinical outcomes and supporting in vitro studies conducted at leading
government and non- government labs.
Last week, a story published on CNN.com (http://ireport.cnn.com/docs/DOC-1157208?ref=feeds%2Flatest),
suggested that our Hemopurifier® might be an ebola treatment cure. In this
regard, I want to clarify that we created the Hemopurifier® to provide a
post-exposure treatment strategy to mitigate illness, suffering, and death
resulting from exposure to viral pathogens. However, we do not represent that
our Hemopurifier® is a cure for ebola. It is designed to augment the ability of
the immune system to overcome infection and to increase the benefit of drug
therapy in disease conditions where an antiviral agent might be indicated.
I also want to provide clarity on what
Hemopurifier® studies have been conducted specific to the ebola virus. On
October 17th, 2007, Dr. Laura Barrientos at the United States (US) Centers for
Disease Control and Prevention (CDC), published a report entitled: "The
Aethlon Hemopurifier®, A Novel Strategy to Address ebola and Marburg
Haemorrhagic Fevers."
The report discussed the potential of the
Aethlon Hemopurifier® as a treatment countermeasure against ebola and other
filoviruses. An excerpt from the report follows:
"The
Hemopurifier® is an extracorporeal device which converges hollow-fiber
filtration technology with immobilized affinity agents to allow for the rapid
physical removal of virus and soluble viral glycoproteins from the blood. The
device basically mimics the natural immune response for clearance of circulating
virus and viral toxins. Initial collaborative efforts between the CDC and
Aethlon Medical have demonstrated rapid clearance of viral particles from cell
culture supernatants (t1/2 20-120 min). The Hemopurifier® was also effective in
removing soluble viral glycoproteins (t1/2 30 min). This knowledge represents
the basis to further investigate in vivo the potential of the Hemopurifier® as
a fast-acting post-exposure intervention to delay disease progression and,
possibly, to improve survival. The data resulting from the CDC-Aethlon
collaboration has led to further studies through a collaborative research and
development agreement with the United States Army Medical Research Institute
for Infectious Diseases (USAMRIID)." The full report can be accessed
online at: http://www.aethlonmedical.com/assets/001/5017.pdf
In a follow-on disclosure, we reported that
the USAMRIID studies documented that the Hemopurifier® captured approximately 50%
of both wild type and mutant strains of ZEBOV (Zaire strain of ebola) from
fluids during one hour in vitro studies. ZEBOV has the highest virus
case-fatality rate, up to 90% in some epidemics, with an average case fatality
rate of approximately 83% over the previous 27 years. USAMRIID, serves as the
lead laboratory for the U.S. Medical Biological Defense Research Program, and
plays a key role in national defense and in infectious disease research.
USAMRIID operates the only laboratory in the Department of Defense (DOD)
equipped to study ebola and other highly hazardous infectious agents requiring
maximum containment at bio-safety level four (BSL-4).
At present, we are preparing to launch the
first FDA approved feasibility studies of Hemopurifier® therapy in the United
States. Under the feasibility study protocol, we will enroll end stage renal
disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to
demonstrate the safety of Hemopurifier therapy in an infectious disease model.
Successful
completion of the feasibility study will set the stage for us to conduct
pivotal studies required for market clearance to treat HCV and other viral
pathogens.
The study will also contribute data toward
the human safety challenge requirement to advance Hemopurifier® therapy as a
broad-spectrum countermeasure against viral bioterror and pandemic threats
(including ebola), whose lethality do not allow for the administration of
clinical efficacy studies. We are actively investigating Emergency Use
Authorization (EUA) approvals based on our previous human treatment experiences
and broad-spectrum validation studies against viral pathogens. We are also
exploring Humanitarian Use Device (HUD) pathways for orphan conditions that
affect fewer than 4,000 individuals in the U.S. each year.
Should the outbreak of deadly viral
pathogen provide us with opportunities to treat, we would first request clarity
from the FDA that our response would not threaten our long-term clinical
objectives in the United States. Additionally, we would request FDA interaction
to provide feedback on data-points that could be collected to support future
EUA and HUD approvals. In this regard, I want to share that we have initiated
our dialog with FDA. The results of these discussions will determine whether we
request an opportunity to treat those infected with ebola virus.
Read this release
in full at http://www.investorideas.com/CO/AEMD/news/2014/08061.asp
About Aethlon Medical
Aethlon Medical creates innovative medical
devices to address life-threatening diseases. The Aethlon ADAPT™ (Adaptive
Dialysis-like Affinity Platform Technology) establishes the basis for a new
class of therapeutics that target the rapid elimination of disease enabling
particles from the circulatory system of treated patients. The lead Aethlon
ADAPT™ product is the Hemopurifier®, a device that addresses a broad-spectrum
of viral pathogens as well as tumor-secreted exosomes that suppress the immune
system of cancer patients. Aethlon is also operating under two government
contracts with the Defense Advanced Research Projects Agency (DARPA) related
the development of a medical device to reduce the incidence of sepsis. Exosome
Sciences, Inc. is a majority owned Aethlon subsidiary that is advancing
exosome-based strategies to diagnose and monitor cancer and infectious disease
progression. Additional information can be found atwww.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 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 treatment for 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 -mining stocks, oil and gas stocks and more...
No comments:
Post a Comment