Results Support Future Study of the
Hemopurifier® as Part of a Machine Perfusion Circuit to
Further Assess its Association with Function of Retrieved
Kidneys
SAN
DIEGO, Aug. 27, 2024 /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 in preprint of
an in vitro study in bioRxiv on August
24, 2024, entitled, "The Hemopurifier® Removes
Extracellular Vesicles and microRNAs From Renal Perfusates
Following Controlled Oxygenated Rewarming of Discarded Donor
Kidneys."
Aethlon Medical's Hemopurifier® is a
therapeutic blood filtration system designed to bind and remove
harmful exosomes and life-threatening viruses from blood and other
biological fluids, qualities which have potential applications in
oncology and infectious diseases, as well as in the organ
transplant setting.
"Kidney transplantation provides the highest
quality of life for those afflicted with end stage renal disease,
yet a significant shortage in the number of donor kidneys currently
exists," stated Steven LaRosa, MD,
Senior Author of the paper and Chief Medical Officer of Aethlon
Medical. "To bridge the gap between recipients and donors, the
criteria for the use of kidneys from deceased brain death and
diseased circulatory death donors has been extended. However,
kidneys from extended criteria donors are associated with higher
rates of poor graft function and acute rejection in recipients. The
release of extracellular vesicles (EVs) and microRNAs from the
donor kidney are hypothesized to play a role in these complications
and are targets for the, Hemopurifier®."
Given that one approach to lessen these
complications and potentially increase the time of assessment of
organ viability is to use machine perfusion on recovered kidneys,
and, based on Aethlon Medical's prior data in COVID-19 and
oncology, it was hypothesized that the Hemopurifier®
could remove EVs and microRNAs from renal perfusates. In this
proof-of-concept study, the company obtained four perfusates from
discarded donor kidneys that had undergone a type of machine
perfusion called Controlled Oxygenated Rewarming (COR). These
perfusates were then pumped over the Hemopurifier® and
analyzed for EV counts and microRNA levels. The results confirmed
the removal of both small and larger size EVs and a significant
reduction in microRNAs.
"While our primary focus is to conduct our
planned clinical trials of the Hemopurifier® in
India and Australia, in patients with solid tumors who
have stable or progressive disease during anti-PD-1 monotherapy,
the data generated by this proof-of-concept study is encouraging
and provides evidence for adding the transplant indication to our
product pipeline," added James
Frakes, Interim Chief Executive Officer and Chief Financial
Officer of Aethlon Medical. "Next steps to consider would be an
additional pre-clinical study comparing mediator removal, renal
function and histopathology in a machine perfusion circuit
performed both with and without incorporation of the
Hemopurifier® on discarded kidneys. Ultimately, a
clinical trial designed to demonstrate that incorporation of the
Hemopurifier® into renal perfusion improves important
clinical endpoints in transplant recipients such as delayed graft
function, graft survival or rejection rates would likely be
required."
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 exosomes from biological fluids, utilizing its
proprietary lectin-based technology. This action has potential
applications in cancer, where exosomes 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 exosomes 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 removing EVs and
microRNAs from renal perfusates; the Company's ability to conduct
its planned oncology clinical trials in Australia and India; the Company's ability to manage and
successfully complete its clinical trials, if initiated; the
Company's ability to conduct clinical trial(s) designed to
demonstrate benefits of the incorporation of
the Hemopurifier® into renal perfusion; 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.