Breaking Medical Technology News: Aethlon (NASDAQ: $AEMD) Receives Ethics Committee Approval for
Hemopurifier® Cancer Trial in India
Aethlon Medical Granted Full Ethics Approval from the Medanta Institutional
Ethics Committee 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, CA, September
19, 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, on September 9, 2024, the Medanta Institutional Ethics Committee (MIEC) 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 one year, followed by annual reviews. This trial has previously been
reviewed by the Institutional Review Board at Medanta. Additionally, the
company previously received a No Objection Certificate (NOC) from DCGI (the
Indian Regulatory Authority) for the proposed oncology trial. The trial will be
conducted by Dr. Ashok K. Vaid and his staff at the Department of Medical
Oncology and Hematology at Medanta Medicity Hospital in Gurugram, India. The
Hemopurifier treatments will be performed by Dr. Puneet Sodhi from the
Department of Nephrology, who has conducted more Hemopurifier treatments than anyone
else in the world.
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"The
approval from the MIEC, coming closely on the heels of our two ethics committee
approvals in Australia, to conduct this early feasibility study, is another
important step in our plan to evaluate use of the Hemopurifier as a treatment
option in multiple tumor types, where cancer associated exosomes may promote
immune suppression and metastasis,” stated Steven LaRosa, MD, Chief Medical
Officer of Aethlon Medical. “We are very pleased that the MIEC accepted our
study protocol and look forward to working, again, with Medanta Hospital with
the expectation of recruiting patients in the fourth calendar quarter of this
year. We believe that the planned safety, feasibility and dose finding trial,
taking place in both India and Australia, in solid tumors in patients failing
treatment with anti-PD-1 antibodies, will help inform future oncology efficacy
trails.”
At present, only
approximately 30% of cancer patients who receive pembrolizumab or nivolumab
treatment for solid tumors will have lasting clinical responses to these
agents. Extracellular vesicles (EVs) produced by tumors have been implicated in
resistance to anti-PD-1 therapies as well as the spread of cancers. 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 EVs in cancer patient
plasma samples.
The primary
endpoint of the approximately nine to 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 PD-1 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 to recruit patients for and
manage its clinical trials and studies; the results of the safety, feasibility
and dose finding study; unforeseen changes in regulatory requirements; 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, 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 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
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