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
SAN
DIEGO, June 18, 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 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.
"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
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SOURCE Aethlon Medical, Inc.