Medical Technology Breaking News: Aethlon Medical (OTCQB:
AEMD) Announces Receipt of IRB Approval to Initiate Hemopurifier™ Clinical
Studies
SAN DIEGO - September 2, 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 received independent internal review
board (IRB) approval to initiate human clinical studies of Hemopurifier®
therapy at DaVita MedCenter Dialysis located in Houston, Texas.
Aethlon
previously disclosed that the United States Food and Drug Administration (FDA)
had approved an Investigational Device Exemption (IDE) that would allow for the
initiation of Hemopurifier® feasibility studies in the United States. As a
result of the independent IRB approval, the Company is now permitted to
initiate the IDE approved study. Enrollment of patients who meet the study
inclusion/exclusion criteria is expected to begin in the coming weeks. The
Hemopurifier® is a first-in-class therapeutic device that targets the rapid
elimination of circulating viruses and tumor-secreted exosomes that suppress
the immune system of cancer patients.
Upon receipt of IDE approval from FDA,
Aethlon initiated discussions with various clinical partner candidates. On
February 26, 2014, the Company disclosed that it had reached an agreement in
principle with DaVita Clinical Research® (DCR) and subsequently disclosed that
it had completed a definitive agreement with DCR on May 20, 2014. DCR is a
specialty contract research organization (CRO) with experience in conducting
more than 300 early phase clinical trials. As a subsidiary of DaVita Healthcare
Partners Inc, DCR has access to one third of the total U.S. ESRD patient
population and maintains a network that exceeds 150 investigative physicians'
practices at more than 250 clinical sites.
Aethlon further disclosed that Dr. Stephen
Z. Fadem had been named Principal Investigator of the IDE approved study. Dr.
Fadem is Chief Medical Officer at Kidney Associates, PLLC and the Medical
Director for the Houston Kidney Center Integrated Service Network at DaVita
Kidney Care, a division of DaVita HealthCare Partners Inc.
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 HCV and other chronic viral
indications. Previous clinical studies of Hemopurifier® therapy have been
conducted 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.
Aethlon's feasibility study will also
contribute safety data to advance the Hemopurifier® as a broad-spectrum
countermeasure against high-risk bioterror and pandemic threats, which are so
lethal they do not allow for the administration of clinical efficacy studies.
In this regard, the Company is pursuing Emergency Use Authorization (EUA)
approvals based on previous human treatment outcomes and pre-clinical
validations against a broad-spectrum of viral pathogens.
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).
Aethlon also disclosed that it may pursue
investigate Humanitarian Use Device (HUD) pathways for orphan indications that
affect fewer than 4,000 individuals in the U.S. each year.
Read this release
in full at http://www.investorideas.com/CO/AEMD/news/2014/09021.asp
About Aethlon Medical
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.
Additional information can be found online at www.AethlonMedical.com or www.ExosomeSciences.com.
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.
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