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, Sept. 16, 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 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.
"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
View original
content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-activation-of-royal-adelaide-hospital-to-begin-patient-screening-and-enrollment-in-hemopurifier-cancer-trial-302247347.html
SOURCE Aethlon Medical, Inc.