Medical Technology Breaking News: Aethlon Medical (OTCBB:
AEMD) Initiates Patient Recruitment for FDA Approved Clinical Study
SAN DIEGO - December 11, 2014 (Investorideas.com newswire)
Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing targeted therapeutic
devices to address infectious diseases and cancer, today announced the
initiation of patient recruitment to support a clinical feasibility study of
Hemopurifier® therapy that is being conducted at DaVita Med Center Dialysis in
Houston, Texas. The study, which will enroll individuals infected with
Hepatitis C virus (HCV) who are also receiving chronic dialysis therapy, is
being conducted under an Investigational Device Exemption (IDE) approved by the
United States Food and Drug Administration (FDA). A detailed description of the
study, including treatment protocol and patient inclusion/exclusion criteria
can be accessed online at www.clinicaltrials.gov.
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. To date, Hemopurifier therapy has
been administered outside the United States in the treatment of Ebola, HIV and
HCV-infected individuals.
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 in an infectious disease model. Upon successful completion
of the feasibility study, Aethlon plans to conduct pivotal efficacy studies
required for market clearance to treat chronic viral indications.
The feasibility study will also contribute
safety data to advance Hemopurifier therapy as a broad-spectrum countermeasure
against category "A" bioterror and pandemic threats that are not
addressed with proven drug or vaccine therapies. The virulence of such viral
threats does not permit for human pivotal (efficacy) studies to be conducted.
In the treatment of Ebola virus, Hemopurifier therapy is available in the US
under emergency-use IDE regulatory provisions. The Company plans to pursue
Humanitarian Use Device (HUD) approval pathways for Ebola and orphan
indications that affect fewer than 4,000 individuals in the U.S. each year.
Previously, in vitro studies of bioterror
and pandemic threats have verified Hemopurifier capture of Ebola hemorrhagic
virus, dengue hemorrhagic virus, lassa hemorrhagic virus, H5N1 avian influenza
(bird flu), the reconstructed 1918 influenza virus (r1918), 2009 H1N1 influenza
virus (swine flu), West Nile virus, and monkeypox, which serves as a model for
human smallpox infection. These studies were conducted with leading government
and non-government research organizations, including The U.S. Army Medical
Research Institute of Infectious Diseases (USAMRIID), The Centers for Disease
Control and Prevention (CDC), The National Institute of Virology (NIV), The
Battelle Biomedical Research Center (BBRC) and The Southwest Foundation for
Biomedical Research (SFBR).
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.
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.
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