SAN DIEGO, June 18, 2020 /PRNewswire/ -- Aethlon Medical,
Inc. (Nasdaq: AEMD), a therapeutic medical device and technology
company focused on unmet needs in viral diseases, oncology and
inflammation, announced today that the U.S. Food and Drug
Administration (FDA) has approved a supplement to the Company's
existing Investigational Device Exemption (IDE) for the Company's
Hemopurifier® in viral disease to allow for the
testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19 in
a new feasibility study.
The feasibility study, which is the device equivalent of a phase
1 trial, will enroll up to 40 subjects at up to 20 centers in the
U.S. Subjects will have established laboratory diagnosis of
COVID-19, be admitted to an intensive care unit (ICU) and will have
acute lung injury and/or severe or life threatening disease among
other criteria.
The Hemopurifier has previously been tested in patients with
hepatitis C virus (HCV) infection and in one patient with Ebola
virus infection. A laboratory version of the Hemopurifier has
also been shown to clear multiple other viruses in vitro
including a model version of the Middle Eastern Respiratory
Syndrome (MERS) virus which is a coronavirus from the same family
as the SARS-CoV-2 virus that causes COVID-19.
Timothy C. Rodell, M.D., Chief
Executive Officer of Aethlon, stated, "We believe that the
Hemopurifier may have the potential to help severely affected
patients with COVID-19. We believe that clearing circulating
virus in these patients, in combination with other supportive
measures, could improve outcomes in this deadly disease."
The Hemopurifier is an FDA designated "Breakthrough Device" for
the treatment of life-threatening viruses that are not addressed
with approved therapies. The Hemopurifier also holds a Breakthrough
Device designation for the treatment of individuals with advanced
or metastatic cancer who are either unresponsive to or intolerant
of standard of care therapy, and with cancer types in which
exosomes have been shown to participate in the development or
severity of the disease.
About Aethlon Medical, Inc.
Aethlon Medical, Inc. is focused on addressing unmet needs in
global health. The Aethlon Hemopurifier is a clinical-stage device
designed to combat cancer and life-threatening viral
infections.
Aethlon also owns 80% of Exosome Sciences, Inc., which is
focused on the discovery of exosomal biomarkers to diagnose and
monitor cancer and neurological disease progression. Additional
information can be found online
at www.AethlonMedical.com and www.ExosomeSciences.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 that involve
risks and uncertainties. Statements containing words such as "may,"
"believe," "anticipate," "expect," "intend," "plan," "project,"
"will," "projections," "estimate," "potentially," "appear" or
similar expressions constitute forward-looking statements. Such
forward-looking statements are subject to significant risks and
uncertainties and actual results may differ materially from the
results anticipated in the forward-looking statements. Factors that
may contribute to such differences include, without limitation,
Aethlon Medical, Inc.'s (the Company) ability to enroll patients
and to successfully complete the Early Feasibility Studies in viral
diseases and cancer and achieve the endpoints for the study or any
future studies with its Hemopurifier or to successfully develop and
commercialize the Hemopurifier. The foregoing list of risks and
uncertainties is illustrative, but is not exhaustive. Additional
factors that could cause results to differ materially from those
anticipated in forward-looking statements can be found under the
caption "Risk Factors" in the Company's Annual Report on Form 10-K
for the year ended March 31, 2019,
and in the Company's other filings with the Securities and Exchange
Commission, including its quarterly Reports on Form 10-Q. Except as
may be required by law, the Company does not intend, nor does it
undertake any duty, to update this information to reflect future
events or circumstances.
Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 x3300
Jfrakes@aethlonmedical.com
Media Contact:
Tony Russo, Ph.D.
Russo Partners, LLC
tony.russo@russopartnersllc.com
212-845-4251
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
212-966-3650
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SOURCE Aethlon Medical, Inc.