Medical Technology Breaking News: Aethlon Medical (OTCBB:
AEMD) Discloses Ebola Treatment Pathways in the United States
SAN DIEGO - October 29, 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 compassionate use access provisions to
support potential requests by qualified physicians and institutes that may seek
to treat ebola virus infection in the United States.
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. At present, no antiviral therapy or
vaccine has proven to be effective against Ebola virus infection in humans.
According to the World Health Organization (WHO), nearly 5,000 deaths have been
attributed to the current ebola virus epidemic.
Based on guidance from FDA, the treatment
of ebola virus infection provides for a unique circumstance where a physician
or health care provider may wish to pursue the compassionate use of
Hemopurifier® therapy based on the serious nature of the disease and absence of
alternative therapies. Compassionate use provisions are typically approved by
FDA on an individual patient basis, but may be expanded to include a small
group.
Aethlon also disclosed that it plans to
submit its first ebola treatment data to the FDA as a means to support the goal
of further expanding treatment access through emergency use regulatory
pathways.
On October 14th, 2014, the Company
announced that Hemopurifier® therapy had been administered to an ebola-infected
patient at Frankfurt University Hospital in Germany. The treatment was
permitted through special approval from The Federal Institute for Drugs and
Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte, BfArM),
an independent federal higher authority within the portfolio of the Federal
Ministry of Health of Germany.
"The administration of Hemopurifier®
therapy in Germany has reinforced the need to clarify defined regulatory
pathways that might allow us to treat ebola infection in the United
States," stated Aethlon founder and CEO, Jim Joyce. "As it relates to
the patient treated in Germany, we respect patient confidentiality and will
report on his response to therapy after Frankfurt University Hospital officials
provide an update on his condition."
In the care of ebola-infected individuals,
the Hemopurifier® targets two unmet medical needs: the rapid elimination of
circulating viruses to inhibit continued progeny virus replication and the
direct targeting of shed glycoproteins that overwhelm the host immune response.
The device can be deployed for use within the global infrastructure of dialysis
and CRRT machines already located in hospitals and clinics.
Aethlon is also preparing to initiate U.S.
clinical studies of Hemopurifier® therapy based on the FDA's approval of an
Investigational Device Exemption (IDE) that was previously submitted by the
Company. 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).
To date, Hemopurifier® therapy has been
successfully administered in approximately one hundred treatment experiences in
health compromised HIV and HCV infected individuals. These studies were
conducted at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and
the Medanta Medicity Institute, all located in India. In vitro validation
studies that demonstrated the ability of the Hemopurifier to capture Zaire and
other strains of ebola virus were conducted by researchers at the United States
Army Medical Research Institute for Infectious Diseases (USAMRIID) and the
United States Centers for Disease Control and Prevention (CDC).
Read this release
in full at http://www.investorideas.com/CO/AEMD/news/2014/10291.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 device that selectively targets the rapid 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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