Results Reinforce the Current Australian
Oncology Clinical Trial and Support Investigation of the
Hemopurifier Across Multiple Indications
SAN
DIEGO, May 14, 2025 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused
on developing products to treat cancer and life-threatening
infectious diseases, today announced the publication
(https://www.biorxiv.org/cgi/content/short/2025.05.09.652772v1) of
a pre-clinical ex vivo study in pre-print vehicle bioRxiv,
entitled, "Ex Vivo Removal of CD41 positive platelet microparticles
from Plasma by a Medical Device containing a Galanthus nivalis
agglutinin (GNA) affinity resin."
Aethlon Medical's Hemopurifier® is a therapeutic
blood filtration system designed to bind and remove harmful
extracellular vesicles (EVs or exosomes) and life-threatening
viruses from blood and other biological fluids, properties that
support its evaluation not only in oncology and infectious
diseases, but also in the organ transplantation and other areas of
significant unmet medical need.
Platelet-derived extracellular vesicles (PD-EVs) are the most
numerous EV population in the body and are released by platelets in
response to a variety of stimuli. The cargo contained within these
EVs have been noted to participate in damage to blood vessels,
activation of immune cells, and spread of tumor cells. Excessive
levels of PD-EVs have been implicated in a myriad of diseases,
including cancer, lupus, systemic sclerosis, multiple sclerosis,
Alzheimer's disease, sepsis, acute and Long COVID.
An independent research team had demonstrated that PD-EVs in
Alzheimer's patients bound to the plant lectin Galanthus nivalis
agglutinin (GNA). We hypothesized that the Aethlon
Hemopurifier, which contains a proprietary GNA affinity resin would
remove platelet derived EVs from plasma. In this experiment two
hundred milliliters of donated healthy human plasma were circulated
over the Aethlon Hemoupurifier (HP) to simulate a clinical HP
session. The study results indicated a 98.5% removal of platelet
-derived EVs at a timepoint equivalent to a 4-hour HP
treatment.
"The data from this ex vivo study is exciting because it
demonstrated for the first time that our device removes
Platelet-derived EV's. This data is also supportive of our ongoing
Oncology clinical trial in Australia as PD-EVs participate in the spread
of cancers. We will be specifically looking at PD-EV removal in our
subjects enrolled in the clinical trial," said Steven P. LaRosa, MD, Chief Medical Officer at
Aethlon Medical and senior author on the paper.
"Beyond Oncology we could envision many indications where
removal of PD-EVs by the Hemopurifier could be a therapeutic
strategy. The findings from this study raise the possibility of a
"pipeline within a device," said James
Frakes, Chief Executive Officer at Aethlon.
Next steps will be to submit the findings of this study to a
peer-review medical journal and specifically study PD-EV removal
and their cargo from plasma samples from diseases of interest.
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 EVs from biological fluids,
utilizing its proprietary lectin-based technology. This action has
potential applications in cancer, where EVs 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 EVs 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 differences include, without
limitation, the Company's ability to raise additional capital and
to successfully complete development of the Hemopurifier; the
Company's ability to successfully demonstrate the utility of the
Hemopurifier in cancer and infectious diseases and in the
transplant setting; the ability of the Hemopurifier to continue to
show removal of platelet -derived EVs at a timepoint equivalent
to a 4-hour HP treatment; the Company's ability to achieve and
realize the anticipated benefits from potential milestones; the
Company's ability to submit applications to and obtain approval
from the additional Ethics Committees in Australia and India, including on the timing expected by the
Company; the Company's ability to initiate and continue its planned
oncology clinical trials in Australia and India, including on the timing expected by the
Company; the Company's ability to manage and successfully complete
its clinical trials, if initiated; the potential impact of
Hemopurifier on the H5N1 Avian Influenza (H5N1 HPAI) virus in dairy
cattle; the Company's ability to successfully manufacture
the Hemopurifier in sufficient quantities for its clinical trials,
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, 2024,
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
Interim 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
917-513-5303
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SOURCE Aethlon Medical, Inc.