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, Sept. 19, 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
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.
"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
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SOURCE Aethlon Medical, Inc.