Phase 1 Clinical Trials of the
Hemopurifier® Designed to Include Patients With Solid
Tumors Who Have Stable or Progressive Disease During Anti-PD-1
Monotherapy Treatment, Such as Keytruda® of
Opdivo®
Interested Clinical Sites Have Initiated
Submissions For Ethics Committee Review
SAN
DIEGO, June 3, 2024 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused
on developing products to treat cancer and life-threatening
infectious diseases, today provided the following update on its
planned phase 1 safety, feasibility and dose-finding clinical
trials of its Hemopurifier® in patients with solid
tumors who have stable or progressive disease during anti-PD-1
monotherapy treatment, such as Keytruda® or
Opdivo®.
"We continue to make progress preparing for our
planned, safety, feasibility and "dose finding" oncology trials in
Australia and India, and want to provide our shareholders
and other constituents with an update, stated Steven LaRosa, MD, Chief Medical Officer of
Aethlon Medical. In early May, we announced new data showing the in
vitro removal of exosomes from cancer patient plasma using a
miniature version of our Hemopurifier®. This data has
been quickly integrated into the required documentation for Ethics
Committees at our potential clinical sites. On May 17, 2024, we provided these documents to the
Contract Research Organizations for these planned clinical trials.
Subsequently, on May 24, 2024, one
potential site submitted the documents to its Ethics Board.
An additional site in Australia and another in India are currently assembling the packages
for submission to their Ethics Committees.
Once we receive the expected Ethics Committee
approvals, we will finalize the Clinical Trial Agreements. After
this, hospitals can begin recruiting patients for the trials.
As a reminder, the target patient population for
these safety, feasibility, and dose finding trials is oncology
patients with solid tumors who are failing their anti-PD-1
monotherapy treatment, such as Keytruda® or
Opdivo®.
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 the approval
by the respective Ethics Boards of interested clinical trial sites
in India and in Australia, the Company's ability
to recruit patients for and manage its clinical trials, 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.