Medical Technology Breaking News: Aethlon Medical (OTCBB:
AEMD) Announces Dengue Virus Treatment Agreement
SAN DIEGO - September 25, 2014 (Investorideas.com newswire)
Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing targeted therapeutic
devices to address infectious disease, cancer and other life-threatening
conditions, announced today that it has entered into an agreement with
Qualtran, LLC that would expand human clinical studies of Hemopurifier® therapy
to include individuals infected with dengue virus, a global health threat,
which is not addressed with approved drug or vaccine therapies. Aethlon is also
in the process of initiating the first FDA approved study of Hemopurifier®
therapy in individuals infected with hepatitis c virus (HCV).
The
Hemopurifier® is a first-in-class therapeutic device that targets the rapid
elimination of circulating viruses and tumor-secreted exosomes that promote
cancer progression. Aethlon disclosed that it will incorporate data from the
proposed dengue treatment study into a Humanitarian Use Device (HUD)
submission, which provides an alternative FDA pathway for obtaining market
approval for medical devices that address disease conditions that affect fewer
than 4,000 individuals in the U.S. per year. Dengue also represents a disease
condition where efficacy treatment studies in the U.S. are not feasible.
The treatment of dengue virus represents a
significant unmet need and serious global health challenge. At present, there
is no approved cure or vaccination against dengue virus, which can develop into
a lethal complication known as dengue hemorrhagic fever. The disease infects
some 100 million people each year, according to the World Health Organization
(WHO), and some experts put the number at three times that level. The number of
dengue cases has been increasing worldwide in part because of urbanization and
in part due to the ability of the mosquito that carries the disease to adapt
for survival in more temperate zones.
Qualtran is a contract research
organization that previously originated and managed clinical studies of
Hemopurifier therapy in HIV and HCV infected individuals at the Apollo
Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity
Institute, all located in India. On behalf of Aethlon Medical, Qualtran also
established a collaborative relationship with the National Institute of
Virology (NIV) that demonstrated the utility of the Hemopurifier® to capture dengue
virus. The NIV is the government of India's primary infectious disease research
institute and is also designated as a collaborating WHO laboratory. As part of
the dengue treatment agreement, Qualtran has agreed to establish multiple
treatment sites and recruit thought leaders from the dengue field to establish
consensus treatment protocols in advance of the 2015 dengue outbreak season.
On September 2, 2014, Aethlon disclosed
that it had received internal review board (IRB) approval to initiate U.S. clinical
studies of Hemopurifier® therapy based on an Investigational Device Exemption
(IDE) that was cleared by the United States Food and Drug Administration (FDA).
The company is now preparing to launch the IDE approved feasibility study,
which will contribute safety data to advance the Hemopurifier® as a
broad-spectrum countermeasure against chronic viral pathogens such as HIV and
HCV, and high-risk bioterror or pandemic threats such as dengue and ebola
virus.
In this regard, the Company has indicated
that it would seek opportunities to expand its treatment indications through
HUD and Emergency Use Authorization (EUA) pathways based on previous human
treatment outcomes and pre-clinical validations against a broad-spectrum of
viral pathogens. 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).
Read this release in
full at http://www.investorideas.com/CO/AEMD/news/2014/09251.asp
About Qualtran, LLC
Qualtran has been instrumental in
conducting clinical trials in the Cardiac, Infectious Disease and COPD space.
For more than a decade, Qualtran has helped companies in the west execute early
and late stage clinical studies in India. The Company also advises on
commercialization strategies and has worked with regulatory authorities and key
opinion leaders in India's fast growing healthcare market. Qualtran has helped
their clients establish relationships with a wide range of Institutions,
including the DCGI (Drug Controller General of India), the ICMR (Indian Council
of Medical Research), the NIV (National Institute of Virology), the Ministry of
Health and many leading medical institutions.
About Aethlon Medical, Inc.
Aethlon
Medical creates medical devices that target unmet therapeutic needs in
infectious disease and cancer. 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, 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:
Jim
Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
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