Medical Technology Breaking News: Aethlon Medical
(AEMDD) Announces Health Canada Approval of Ebola Treatment Protocol
SAN DIEGO - May 13, 2015 (Investorideas.com newswire) Aethlon
Medical, Inc. (OTCQB:AEMD, AEMDD), the pioneer in developing targeted therapeutic
devices to address infectious diseases and cancer, today disclosed that the
Medical Devices Bureau of Health Canada has approved a clinical study protocol
to treat Ebola-infected individuals with the Aethlon Hemopurifier®. The
Hemopurifier is a first-in-class affinity biofiltration device designed for the
broad-spectrum elimination of viral pathogens from the circulatory system of
infected individuals. The device targets antiviral drug resistance and serves
as a first-line countermeasure against Ebola and other life-threatening viruses
that are not addressed with proven drug therapies. Health Canada is the Federal
department responsible for overseeing the health of Canadian citizens.
The
Health Canada approved protocol is entitled, "The Treatment of Ebola Virus
Disease (EVD) in Humans with the Aethlon Hemopurifier Lectin Affinity
Plasmapheresis Device". The protocol allows for an investigational study
of Hemopurifier therapy to be conducted in up to 3 human subjects. The
objective of the study is to standardize and evaluate the use of the
Hemopurifier as supportive care in the treatment of EVD. There is no assurance
that the investigational study will result in the collection of clinical data
that would support Health Canada licensing requirements. Aethlon further
disclosed that the Ebola study protocol had also been approved by the
University Health Network (UHN) Research Ethics Board, based in Toronto,
Ontario.
Previously, Aethlon
disclosed that the United States (U.S.) Food and Drug Administration (FDA)
approved a clinical protocol to treat Ebola-infected individuals with
Hemopurifier therapy in the U.S. The Company has also submitted a Humanitarian
Use Device (HUD) application with FDA to support potential market clearance of
the Hemopurifier as a treatment for EVD.
The first
administration of Hemopurifier therapy to an ebola-infected individual occurred
at Frankfurt University Hospital in Germany. On November 14, 2014, the
resulting Hemopurifier treatment data was presented at the American Society of
Nephrology (ASN) Annual Meeting by Helmut Geiger, M.D., Chief of Nephrology at
Goethe University, Frankfurt University Hospital. Dr. Geiger reported that 242
million Ebola viruses were captured within the Hemopurifier during treatment, a
number verified by a post-treatment elution protocol. The elution protocol has
since be repeated, which resulted in second measurement of 253 million copies
of Ebola virus captured within the Hemopurifier.
Dr. Geiger also
reported that 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). A post-treatment viral load measurement was
reported to be 1,000 copies/ml. The treatment was well tolerated with no
adverse events reported. At the time of treatment, the Ebola patient was
comatose and suffering from multiple organ failure, which required mechanical
ventilation, continuous dialysis and the administration of vasopressor
medications. The patient made a full recovery and returned home to his family.
A publication in the journal "Blood Purification" entitled,
"Extracorporeal Virus Elimination for the Treatment of Severe Ebola Virus
Disease – First Experience with Lectin Affinity Plasmapheresis." can be
accessed online at: http://www.karger.com/Article/Abstract/375229
Read this release
in full at http://www.investorideas.com/CO/AEMD/news/2015/05131.asp
About Aethlon Medical, Inc.
Aethlon Medical
creates affinity biofiltration devices to treat life-threatening diseases. Our
lead therapeutic candidate is the Aethlon Hemopurifier®, a first-in-class
device that targets the rapid elimination of infectious viruses and cancer
promoting exosomes from the circulatory system of treated individuals. Our
majority owned subsidiary Exosome Sciences, Inc., is advancing exosome-based
liquid biopsies to diagnose and monitor Cancer and Chronic Traumatic
Encephalopathy (CTE), a neurodegenerative disorder often found in individuals
with a history of repetitive brain trauma.
About The Aethlon Hemopurifier®
Of the hundreds of
viruses known to be infectious to man, antiviral drug therapies are approved
for fewer than ten. The Aethlon Hemopurifier® provides a broad-spectrum
therapeutic strategy to address drug resistant viral pathogens. To date,
Hemopurifier therapy has been administered to individuals infected with Ebola
virus (Ebola), Hepatitis C virus (HCV) and the Human Immunodeficiency virus
(HIV). Time Magazine recently named the Hemopurifier to their list of 'Top 25
Inventions" and "The 11 Most Remarkable Advances in Healthcare."
Beyond human treatment experiences, pre-clinical Hemopurifier studies have
validated the capture of some of world's deadliest pathogens. These include:
Dengue hemorrhagic fever, Lassa hemorrhagic fever, H5N1 avian influenza, H1N1
swine flu virus, the reconstructed 1918 influenza virus, West Nile virus and
Vaccinia and Monkeypox, which serve as models for human smallpox infection.
U.S. clinical progression of Hemopurifier therapy is being advanced under FDA
approved clinical studies.
Aethlon is also
investigating the use of Hemopurifier therapy to capture tumor-derived
exosomes, a significant unaddressed therapeutic target in cancer care.
Tumor-derived exosomes promote cancer progression through multiple mechanisms,
which include seeding the spread of metastasis and direct suppression of the
immune response. In regards to our therapeutic mechanism of action, the Hemopurifier
incorporates a patented affinity technique that allows for selective binding to
a unique structure that resides on the surface of tumor-derived exosomes and
glycoproteins that coat infectious viruses. Additional information can be found
online at www.AethlonMedical.com or you can connect with us on on 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.
Contacts:
David
Zazoff
MDM Worldwide Solutions
646-403-3554
MDM Worldwide Solutions
646-403-3554
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