SAN
DIEGO, Dec. 20, 2024 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused
on developing products to treat cancer and life-threatening
infectious diseases, today provided a statement of its
investigational medical device with respect to H5N1 avian influenza
"Bird Flu."
Aethlon has recently received a number of inquiries regarding
the potential utility of its Hemopurifier device in the treatment
of Bird Flu. These inquiries come on the heels of the reporting of
isolation of Bird Flu in dairy cows, 60 human cases in eight states
including a case of severe infection in Louisiana, and yesterday's declaration of a
state of emergency in California.
The Aethlon Hemopurifier is an investigational extracorporeal
medical device designed to remove enveloped viruses and
extracellular vesicles from the bloodstream. The device
incorporates plasma separation, size exclusion, and affinity
binding to a proprietary resin containing the plant lectin
Galanthus nivalis agglutinin (GNA) bound to a medical grade
diatomaceous earth. Enveloped viruses and extracellular vesicles
contain the sugar mannose on their surface, which is the
therapeutic target of the GNA.
Aethlon has previously contracted Battelle labs to examine the
in vitro removal of influenza viruses including H5N1 by a scaled
down version of the Aethlon Hemopurifier. In this experiment, cell
culture media was spiked with the H5N1 virus and continuously
circulated over the device. Samples were taken periodically to
examine viral removal by the device. In this study, a miniature
version of the device removed 99% of H5N1 following 6 hours of
treatment.
While the Aethlon Hemopurifier has not yet been used to treat
patients with severe influenza, including those infected with H5N1,
it has been used in 38 patients across 164 distinct treatment
sessions, targeting diseases such as hepatitis C, HIV, and in
patients critically ill due to COVID-19 and Ebola. The Hemopurifier
has a "breakthrough device" designation with the FDA for
life-threatening viruses for which there is no effective
treatment.
Current treatment guidelines from the Center for Disease Control
and Prevention
(https://www.cdc.gov/bird-flu/hcp/novel-av-treatment-guidance/),
for hospitalized patients with suspected Bird Flu (H5N1), are to
initiate antiviral therapy as soon as possible with Oseltamivir,
with or without combination therapy with Baloxavir. Clinical
failures during Oseltamavir therapy due to the development of
antiviral resistance have been observed in hospitalized patients
with H5N1. This phenomenon raises the possibility that novel
treatment strategies may be required. Aethlon Medical will monitor
this situation closely and interact with hospitals, the state of
California, and the FDA as
appropriate if cases mount and currently available treatments are
not effective.
About Aethlon and the Hemopurifier®
Aethlon Medical is
a medical therapeutic company focused on developing the
Hemopurifier, a clinical stage immunotherapeutic device which is
designed to combat cancer and life-threatening viral infections and
for use in organ transplantation. In human studies, the
Hemopurifier has demonstrated the removal of life-threatening
viruses and in pre-clinical studies, the Hemopurifier has
demonstrated the removal of harmful extracellular vesicles from
biological fluids, utilizing its proprietary lectin-based
technology. This action has potential applications in cancer, where
extracellular vesicles may promote immune suppression and
metastasis, and in life-threatening infectious diseases. The
Hemopurifier is a U.S. Food and Drug Administration (FDA)
designated Breakthrough Device indicated 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 extracellular vesicles have been shown to
participate in the development or severity of the disease. The
Hemopurifier also holds an FDA Breakthrough Device designation and
an open Investigational Device Exemption (IDE) application related
to the treatment of life-threatening viruses that are not addressed
with approved therapies.
Additional information can be found at
www.AethlonMedical.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" 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. These forward-looking statements are
based upon Aethlon's current expectations and involve assumptions
that may never materialize or may prove to be incorrect. Factors
that may contribute to such include, without limitation, the
ability of the Hemopurifier to capture H5N1 Bird Flu; the
possibility of novel treatment strategies; the efficacy of the
Hemopurifier and virus removal after various treatment
times; the use and efficacy of the Hemopurifier being
utilized in treatment session for patients with hepatitis C,
HIV, as well in patients with critical illness due to COVID-19 and
Ebola; the occurrence and possible continuation of the state of
emergency declaration in California and reported infections in other
states; and other potential risks. 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,
2023, and in the Company's other filings with the Securities
and Exchange Commission, including its quarterly Reports on Form
10-Q. All forward-looking statements contained in this press
release speak only as of the date on which they were made. 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 Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
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SOURCE Aethlon Medical, Inc.
