Medical Technology Breaking News: Aethlon Medical (OTCBB:
AEMD) Announces Approval of Ebola Treatment Protocol
SAN DIEGO - January 2, 2015 (Investorideas.com newswire)
Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing targeted therapeutic
devices to address infectious diseases and cancer, today announced that the
United States Food and Drug Administration (FDA) has approved a clinical
protocol to treat Ebola-infected individuals in the U.S. with the Aethlon
Hemopurifier®. In the treatment of viral pathogens, the Hemopurifier® is a
first-in-class bio-filtration device designed for the single-use removal of
viruses and shed glycoproteins from the circulatory system of infected individuals.
The device targets antiviral drug resistance and serves as a first-line
countermeasure against Ebola and other viruses that are not addressed with
proven drug therapies.
The
approved Ebola treatment protocol allows for an investigational study to be
conducted at up to 10 U.S. clinical sites, and up to 20 U.S. subjects may be
enrolled to receive the treatment protocol. Patients who meet the enrollment
criteria will receive a daily six to eight hour administration of Hemopurifier®
therapy until the point that Ebola viral load drops below 1000 copies/ml. The
goal of the study is to standardize and evaluate the use of the Hemopurifier®
as supportive care in the treatment of Ebola virus disease.
The Ebola treatment protocol resulted from
the submission of a supplement to an Investigation Device Exemption (IDE)
previously approved by FDA. The supplement was entitled, "Treatment of
Ebola Virus Disease (EVD) in Humans with the Aethlon Hemopurifier® Lectin
Affinity Plasmapheresis Device." Based on the previously approved IDE
protocol, Aethlon is conducting a clinical feasibility study of Hemopurifier®
therapy in individuals infected with Hepatitis C virus (HCV) who are also
receiving chronic dialysis therapy. A detailed description of the HCV study,
including treatment protocol and patient inclusion/exclusion criteria can be
accessed online at www.clinicaltrials.gov.
As the approved Ebola treatment protocol is
a deviation from the HCV protocol, Aethlon is required to clearly distinguish
data collected in the supplemental Ebola protocol study from data derived from
the Company's HCV trials. The Company may not combine data from the two
studies. Aethlon must also comply with specified patient protection procedures
established by the applicable institution including its institutional review
board approval prior to treating a patient under the supplement protocol. The
Company must also report any unanticipated adverse events resulting from the
supplement protocol to the FDA within 10 working days of the use of the device.
There is no assurance that any Ebola-infected patients will be treated under
the protocol.
Aethlon previously reported that
Hemopurifier® therapy was successfully administered to a critically-ill Ebola
patient 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 unconscious and suffering from multiple
organ failure, which required mechanical ventilation, continuous dialysis and
the administration of vasopressor medications. The patient has since made a
full recovery and returned home to his family.
Time Magazine recently named the Aethlon
Hemopurifier® to be one of the 25 best inventions of 2014. The magazine also
included the Hemopurifier® as one of the 11 most remarkable advances in
healthcare in 2014.
Read this release
in full at http://www.investorideas.com/CO/AEMD/news/2015/01021.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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