Aethlon Medical Granted Full Ethics Approval
From the Human Research Ethics Committee at Central Adelaide Local
Health Network for a Safety, Feasibility, and Dose Finding Study of
its Hemopurifier® in Cancer Patients with Solid Tumors Not
Responding to Anti-PD-1 Antibodies
SAN
DIEGO, June 18, 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 that, on June, 13, 2024, the
Human Research Ethics Committee (HREC) of the Central Adelaide
Local Health Network (CALHN) granted full ethics approval for
Aethlon's safety, feasibility and dose-finding clinical trial of
the Hemopurifier® in cancer 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 approval is valid for three
years, until June 13, 2027. The trial
will be conducted by Prof. Michael
Brown and his staff at the Cancer Clinical Trials Unit,
CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.
Currently, only approximately 30% of patients who receive
pembrolizumab or nivolumab will have lasting clinical responses to
these agents. Extracellular vesicles (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 approval from the Human Research Ethics Committee at
Central Adelaide Local Health Network marks a significant milestone
for Aethlon, as they deemed that our clinical study meets the
requirements of the Australia's
National Statement on Ethical Conduct in Human Research," stated
Steven LaRosa, MD, Chief Medical
Officer of Aethlon Medical. "We look forward to working closely
with Prof. Brown and his staff, and with our Contract Research
Organizations, NAMSA and ReSQ Clinical Research. The next steps
include submission to the Therapeutic Goods Administration, the
national health regulatory agency of Australia, obtaining approval from the CALHN
Research Governance Committee, and conducting a site initiation
visit to facilitate patient enrollment. Following this Ethics Board
approval, we plan to submit to the Ethics Committees at two
additional sites in Australia and
one in India."
The primary endpoint of the approximate 18-patient, safety,
feasibility and dose-finding trial is safety. The trial will
monitor any adverse events and clinically significant changes in
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 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 work with
the requisite personnel and complete the next steps to facilitate
patient enrollment, the Company's ability to submit
additional studies and obtain the approval by the additional
respective Ethics Boards of interested clinical trial sites in
India and in Australia, the Company's ability to
recruit patients for and 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
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SOURCE Aethlon Medical, Inc.