Translational Study Provides Pre-Clinical
Evidence to Support The Design of a Phase 1 Study of the
Hemopurifier In Cancer Patients With Solid Tumors Treated With
Anti-PD-1 Antibodies
SAN
DIEGO, May 10, 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 positive results from an in
vitro binding study of its Hemopurifier® in removing extracellular
vesicles (EVs) from plasma. The translational study provides
pre-clinical evidence to support Aethlon's planned phase 1 safety,
feasibility and dose-finding clinical trials of the Hemopurifier in
patients with solid tumors who have stable or progressive disease
during anti-PD-1 monotherapy treatment, such as Keytruda® or
Opdivo®.
"The positive data from this in vitro binding
study of the Hemopurifier is an important step forward for Aethlon,
ahead of the potential start of our planned phase 1 oncology trials
in Australia and India," stated James
Frakes, Interim Chief Executive Officer and Chief Financial
Officer of Aethlon Medical. "We have previously demonstrated that
our Hemopurifier can reduce EVs isolated from cancer patient plasma
when those EVs are placed in a buffer solution. However, ahead of
our oncology study, we wanted to conduct a more robust
translational study, specifically examining the removal of EVs and
EVs with PD-L1 on their surface directly from plasma. To that end,
we acquired small volumes of plasma from patients treated with
anti-PD-1 antibodies from a third-party lab and ran the samples
over a miniature version of our Hemopurifier. We then had the
samples examined by Cellarcus Biosciences, Inc., an independent
commercial lab with recognized expertise in EV quantification and
phenotyping, by the widely accepted methodology of vesicle flow
cytometry. This data was then analyzed by independent statisticians
at NAMSA, the contract research organization (CRO) for our planned
Australian oncology study."
Mr. Frakes concluded, "The descriptive statistics
from the CRO support the removal of EVs by the Hemopurifier
directly from cancer patient plasma, although the small numbers of
EVs bearing PD-L1 did not allow us to conclude a removal of this
particular EV subset. We look forward to adding this data to our
Clinical Investigator Brochure and submitting it to the Ethics
Committees at the interested clinical sites, as the next step for
our planned phase 1 oncology trials in Australia and India."
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
successfully complete development of the Hemopurifier and to
successfully demonstrate the utility of the Hemopurifier in
patients with solid tumors in our planned oncology clinical
trials, , the Company's ability to obtain the approval
by the respective Ethics Boards of interested clinical trial sites
in India and in Australia; the Company's ability
to manage 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, 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
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.