Bellberry Human Research Ethics Committee
Granted Full Ethics Approval to the Pindara Private Hospital for a
Safety, Feasibility, and Dose Finding Study of Aethlon's
Hemopurifier® in Patients with Solid Tumors Not Responding to
Anti-PD-1 Antibodies
SAN
DIEGO, Aug. 12, 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 August 6, 2024, the Bellberry Human Research
Ethics Committee (BHREC) granted full ethics approval to the
Pindara Private Hospital for a 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 Merck's Keytruda® (pembrolizumab) or Bristol
Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier
Study). The approval is valid for one year, until August 6, 2025. The trial will be conducted by
Dr. Marco Matos and his staff at the
Pindara Private Hospital, located in Queensland, Australia.
"We are quite pleased that the BHREC accepted our responses to
their thoughtful questions during their review and determined that
our study meets the requirements of the National Statement
application. Dr. Matos and his research team have a proven track
record of enrollment in device trials in oncology patients that
provides momentum to these trials," stated Steven LaRosa, MD, Chief Medical Officer of
Aethlon Medical. "This is the second ethics committee approval we
have received for our oncology trial in Australia after receiving approval from the
ethics committee for Royal Adelaide Hospital in June."
Dr. LaRosa continued, "The next step is to receive approval from
the Research Governance Office at each hospital which reviews
indemnities and insurance. Once these approvals are obtained,
Aethlon, in concert with our Australian Contract Research
Organization, ReSQ, will conduct Site Initiation Visits (SIVs),
after which patient enrollment may proceed."
Currently, 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 exosomes in cancer patient
plasma samples.
The primary endpoint of the approximate 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 and safety of the Hemopurifier in patients with solid
tumors in our planned oncology clinical trials; the
Company's ability to obtain the approval by the respective Ethics
Boards of interested clinical trial sites in India and in Australia; the Company's ability to
obtain approvals from Research Governance Offices at relevant
hospitals and complete site initiation visits in a timely manner;
the Company's ability to recruit patients for and manage its
clinical trials and studies; 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,
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
917-513-5303
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SOURCE Aethlon Medical, Inc.