First Patient enrolled and treated at the Cancer Clinical
Trial Unit, CALHN, Royal Adelaide Hospital
Aethlon Advances Hemopurifier® Study in Solid Tumors Not
Responding to Anti-PD-1 Antibodies
SAN
DIEGO, Jan. 29, 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 first 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
enrolled on October 29, 2024, by
Prof. Michael Brown and his staff at
the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in
Australia, and treated with the
Hemopurifer on January 29, 2025, by
Prof. Toby Coates and the dialysis
staff.
The patient treated was determined to have progressive disease
following a two-month "run -in" period of the anti-PD-1 drug
Nivolumab. During this period, serial measurements of
extracellular vesicles (EVs) and anti-tumor T cell activity were
obtained. The patient was then treated with the Aethlon
Hemopurifier for 4 hours on a single day and tolerated the
procedure without complications. The patient will have follow-up
safety visits, EV and T cell measurements as well as imaging for
clinical response.
"Treatment of the first patient represents the achievement of a
critical milestone for Aethlon Medical in the clinical development
of the Hemopurifier in Oncology," stated Steven LaRosa, MD, Chief Medical Officer of
Aethlon Medical. "We are excited to receive the data from this
first treatment cohort, anticipating insights into how the
Hemopurifier may reduce tumor-derived extracellular vesicles and
enhance T cell activity against tumors".
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; 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. 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
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.