Breaking
Medical Technology News: Aethlon Medical (Nasdaq: $AEMD) Announces Activation of Royal
Adelaide Hospital to Begin Patient Screening and Enrollment in Hemopurifier®
Cancer Trial
Aethlon’s Trial
is a Safety, Feasibility, and Dose Finding Study of the Hemopurifier® in
Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies
SAN DIEGO, CA - September 16, 2024
(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 that the Cancer Clinical
Trial Unit at Royal Adelaide Hospital was activated on September 10, 2024 to
begin screening and enrolling patients in its safety, feasibility and
dose-finding clinical trial of the Hemopurifier® in 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 trial will be conducted by Prof. Michael Brown and his
staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in
Australia.
The activation
follows the previously announced approval by the Human Research Ethics
Committee at Central Adelaide Local Health Network on June 13, 2024, and the Research
Governance office at Royal Adelaide Hospital, on September, 3 2024, as well as
the notification of the Therapeutic Good Administration (TGA) and completion of
a Site Initiation Visit on September 9, 2024.
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"The activation
of the investigative site at the Royal Adelaide Hospital marks a significant
milestone for Aethlon, allowing the site to screen and enroll patients in this
important clinical trial,” 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 (CROs), NAMSA and ReSQ
Clinical Research, to begin enrollment and data collection. Going forward, we
plan to activate a second site in Australia and also expect to receive an
Ethics Committee approval for a clinical site in India.”
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 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 whether 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 to obtain Ethics
Committee approval for a clinical site in India, the Company’s ability to activate a second site in
Australia, the Company’s ability to recruit and enroll patients for and manage
its clinical trials at the Royal Adelaide Hospital and other site locations,
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
Aethlon Medical Inc. (Nasdaq:AEMD) is a featured
biotech stock on Investorideas.com
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