Aethlon Medical (OTCBB:
AEMD) Discloses Expanded Access "Emergency Use" Pathway to Treat
Ebola in the United States
SAN DIEGO - November 19, 2014 (Investorideas.com newswire)
Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing targeted therapeutic
devices to address infectious disease and cancer, disclosed today that it will
provide Hemopurifier® therapy under FDA expanded access "emergency
use" provisions to support requests from qualified physicians and
institutes that may seek to treat ebola virus infection in the United States.
Aethlon
previously disclosed that it would provide Hemopurifier® therapy on a
humanitarian basis through FDA compassionate use access provisions, which allow
for the use of an investigational device to treat an individual patient or
small group based on clearance by FDA prior to treatment.
Based on FDA guidance, Aethlon will now
provide Hemopurifier® therapy to treat Ebola infection through expanded access
"emergency use" provisions in the United States. Expanded access
"emergency use" of an investigational device does not require advance
FDA approval for life threatening circumstances for which an alternative
therapy is not available. At present, no antiviral therapy or vaccine has
proven to be effective against Ebola virus infection in humans.
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. In the treatment of Ebola, Aethlon recently announced that
Hemopurifier® therapy was administered to Ugandan physician, who was infected
with Ebola in Sierra Leone where he was treating Ebola patients. At the time of
treatment, which occurred at Frankfurt University Hospital in Germany, the
patient was unconscious and suffering from multiple organ failure.
The patient's viral load prior to the
administration of a single 6.5-hour Hemopurifier® treatment was measured at
400,000 virus copies per milliliter of blood (copies/ml). Post-treatment viral
load was measured at 1,000 copies/ml and never again rose above that level. The
treatment was well tolerated with no adverse events reported. Additionally, a
post-treatment elution protocol verified that 242 million Ebola viruses were
captured within the Hemopurifier® during treatment. Since the administration of
Hemopurifier® therapy, Frankfurt University Hospital officials have reported
that the Ebola virus is no longer detectable in the patient's blood and full
recovery is expected.
Aethlon will soon begin the first U.S.
clinical Hemopurifier® studies following the United States Food and Drug
Administration's (FDA)'s approval of an Investigational Device Exemption (IDE).
The study will contribute safety data to advance the device as a broad-spectrum
countermeasure against pandemic threats, including Ebola and chronic viral
pathogens such as HIV and Hepatitis C (HCV).
Read this release
in full at: http://www.investorideas.com/CO/AEMD/news/2014/11191.asp
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. For
more information, please visit http://www.aethlonmedical.com and connect with the
Company on Twitter, LinkedIn,
Facebook and Google+.
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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