Breaking Medical Technology News: Aethlon Medical (NASDAQ: $AEMD) Receives
Second Ethics Committee Approval for Hemopurifier® Cancer Trial
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, CA - August 12, 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 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."
This news is paid advertisement/ news disseminated
on behalf of/issued on behalf of Aethlon Medical Inc.
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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.
Investor Contact:
Susan
Noonan
S.A.
Noonan Communications, LLC
917-513-5303
Aethlon
Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com
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