Medical
Tech Stock Aethlon Medical (Nasdaq:
$AEMD) Treats Second Patient
in Australian Hemopurifier Cancer Trial
Second Patient in first cohort
enrolled and treated at the Royal North Shore Hospital/University of Sydney
Aethlon Advances
Hemopurifier® Study in Solid Tumors Not Responding to Anti-PD-1 Antibodies
Aethlon Medical (Nasdaq:
AEMD) Hemopurifier®
SAN
DIEGO, CA, June 18, 2025 - (Investorideas.com Newswire) Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on
developing products to treat cancer and life-threatening infectious diseases,
today announced a significant milestone:
the treatment of the second patient with the Hemopurifier in its Australian
safety, feasibility and dose-finding clinical trial of the Hemopurifier. This
trial is designed for patients with solid tumors who have stable or progressive
disease during anti-PD-1 monotherapy treatment, such as Keytruda®
(pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The
patient was treated with the Hemopurifier June 11, 2025 by Genesis Care and Royal
North Shore Hospital/University of Sydney. Professor Stephen Clarke, Medical
Oncologist, is the Principal Investigator for the study and the Hemopurifier
session was supervised by Dr. Emma O’Lone.
Ongoing progress
has been made in our Australian Oncology trial of the Hemopurifier in
participants with solid tumors not responding to anti-PD-1 agents. We have now
completed Hemopurifier treatments in 2 participants in the first cohort. Our
first participant completed the Hemopurifier treatment at Royal Adelaide
Hospital on January 29, 2025. Participant # 2 was treated with the Hemopurifier
at Royal North Shore/University of Sydney on June 2, 2025. Both participants
completed the 4-hour Hemopurifier treatment without device deficiencies or
immediate complications. As of June 10, 2025, both patients have completed the
pre-specified 7-day safety follow-up period that will be presented to an
independent Data Safety Monitoring Board (DSMB) following the treatment of a
third patient in the cohort.
The DSMB will
review safety data on this first cohort and provide a recommendation to Aethlon
Medical Senior Leadership about advancing to the second treatment cohort where
3 participants will receive 2 Hemopurifier treatments during a one-week period.
We would expect data on extracellular removal by the Hemopurifier and effects
on anti-tumor T cell activity on participants in the first cohort in
approximately three months following enrollment of the third patient.
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“We are pleased
that both patients treated with the Hemopurifier thus far have tolerated the 4-hour
treatment without immediate complications. We look forward to enrolling the
third participant to trigger a safety review of the first cohort by the DSMB.”
stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical.
Currently, only
approximately 30-40% of patients who receive pembrolizumab or nivolumab will
have lasting clinical responses to these agents. EVs produced by tumors have
been implicated in the spread of cancers as well as the resistance to anti-PD-1
therapies. The Aethlon Hemopurifier has been designed to bind and remove these
EVs from the bloodstream, which may improve therapeutic response rates to
anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown
to reduce the number of exosomes from the plasma of cancer patient samples.
The primary
endpoint of the approximately 18-patient, safety, feasibility, and dose-finding
trial is the incidence of adverse events and clinically significant changes in
safety lab tests of Hemopurifier treated patients with solid tumors with stable
or progressive disease at different treatment intervals, after a two-month
run-in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who
do not respond to the therapy will be eligible to enter the Hemopurifier period
of the study where sequential cohorts will receive 1, 2, or 3 Hemopurifier
treatments during a one-week period. In addition to monitoring safety, the
study is designed to examine the number of Hemopurifier treatments needed to
decrease the concentration of EVs and if these changes in EV concentrations
improve the body’s own natural ability to attack tumor cells. These exploratory
central laboratory analyses are expected to inform the design of a subsequent
efficacy and safety, Premarket Approval (PMA), study required by regulatory
agencies.
About the Hemopurifier®
The Aethlon Hemopurifier
is an investigational medical device designed to remove enveloped viruses and
tumor-derived extracellular vesicles from circulation. The Hemopurifier is an
extracorporeal device that is used in concert with a blood pump. The device
incorporates plasma separation, size exclusion, and affinity binding to an
affinity resin containing a plant lectin. Mannose on the surface of enveloped
viruses and extracellular vesicles binds to the plant lectin within the device.
Extracellular vesicles released from solid tumors have been implicated in the
spread of cancers known as metastasis as well as in the resistance to
immunotherapy and chemotherapeutic agents. Removal of enveloped viruses and
extracellular vesicles has been observed in in vitro studies and in human
subjects. The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for
the treatment of individuals with advanced or metastatic cancer who are either
unresponsive to or intolerant of standard-of-care therapy. 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.
About Aethlon Medical,
Inc.
Aethlon Medical, Inc. is a
publicly traded medical device company based in San Diego, California. The
company aims to leverage its therapeutic device, The Hemopurifier, to remove
enveloped viruses and extracellular vesicles from biologic fluids. Aethlon
Medical’s innovative platform is enabling the development of new options for
cancer and life-threatening infectious diseases. For more information on
Aethlon Medical, Inc. and its clinical development program, visit www.AethlonMedical.com and follow the company on
LinkedIn.
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 number of patients who receive pembrolizumab or
nivolumab that will have lasting clinical responses to these agents; device
deficiencies or immediate complications; the possibility
of novel treatment strategies; how the
Hemopurifier may reduce tumor-derived extracellular vesicles and enhance T cell
activity against tumors; the efficacy of continued clinical trials; and/or the
number of patients enrolled in each cohort. 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
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
Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock
on Investorideas.com
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