Medical
Tech Stock Aethlon Medical, Inc. (NASDAQ: AEMD) Reports Positive Data Safety
Monitoring Board Review and Recommendation to Advance to Next Clinical Trial Cohort
SAN DIEGO, CA, July 15, 2025 – (Investorideas.com
Newswire) Aethlon Medical, Inc. (Nasdaq: AEMD), a clinical-stage biotechnology company developing the
investigational Aethlon Hemopurifier®, an extracorporeal device for Oncology and other indications, today
announced that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing clinical trial AEMD-2022-06 has
completed its scheduled safety review and recommended advancing to the next
patient cohort without modification.
The trial, titled “Safety, Feasibility, and Dose-Finding Study of
Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or
Progressive Disease While on a Treatment That Includes Pembrolizumab or
Nivolumab”, is being conducted to assess the Hemopurifier’s safety,
feasibility, and optimal dosing.
The DSMB- comprising independent medical experts in nephrology and
oncology- reviewed data from the initial cohort of three participants, each of
whom received a single 4-hour Hemopurifier treatment. Based on their evaluation, the board found no
safety concerns and confirmed that the Hemopurifier continues to demonstrate a
favorable safety and tolerability profile. To date, no serious adverse events
(SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been
reported.
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"The DSMB's positive recommendation is encouraging and underscores
the favorable safety profile observed to date in patients with cancer,"
according to Steven LaRosa, M.D, Chief Medical Officer of Aethlon Medical.
"This marks a significant step forward in the clinical development program
for the Hemopurifier in Oncology and brings the company closer to potentially
addressing the significant unmet medical need for the approximately 60-70% of
patients with cancer who do not experience a lasting clinical response to
anti-PD-1 immunotherapy.”
Enrollment for Cohort 2 is now open. In this phase, participants will
receive two Hemopurifier treatments over a one-week period at the study’s three
active clinical sites in Australia. This trial, which aims to enroll
approximately 9 to 18-patients, is designed to evaluate the safety, feasibility
of administering the Hemopurifier at varying dosing intervals in patients with
solid tumors who have stable or progressive disease, while receiving treatment
that includes Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®).
The primary endpoint of this trial is the incidence of adverse events
and clinically significant changes in safety laboratory tests of Hemopurifier-
treated patients. In addition to safety monitoring, 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 findings are expected
to inform the design of a future efficacy and safety, Premarket Approval (PMA),
study required by regulatory authorities.
Aethlon Medical, Inc. remains committed to advancing the Hemopurifier for
use in oncology and will continue to provide updates as the clinical trial
progresses.
About
the Hemopurifier®
The
Aethlon Hemopurifier is an investigational medical device designed to remove
enveloped viruses and tumor-derived extracellular vesicles (EVs) from
circulation. It is used extracorporeally with a blood pump and combines plasma
separation, size exclusion, and affinity binding using a plant lectin resin
that targets mannose-rich surfaces found on EVs and viruses. EVs released by
solid tumors are believed to play a role in metastasis and the resistance to
immunotherapies and chemotherapy. Removal of enveloped viruses and
extracellular vesicles has been demonstrated in both vitro studies and human
subjects.
The
Hemopurifier holds a U.S. Food and Drug Breakthrough Device for:
·
The
treatment of individuals with advanced or metastatic cancer unresponsive to or
intolerant of standard-of-care therapy; and
·
The
treatment of life-threatening viruses not addressed with approved therapies.
The
Hemopurifier is being developed under an open Investigational Device Exemption
(IDE) for both indications.
About Aethlon Medical, Inc.
Aethlon
Medical, Inc. (Nasdaq: AEMD) is a clinical stage medical device company headquartered
in San Diego, California. Aethlon is advancing the Hemopurifier, to address
unmet needs in oncology and infectious disease, using a novel platform designed
to selectively remove circulation pathogenic targets from biologic fluids. For
more information visit www.AethlonMedical.com
and follow the company on LinkedIn.
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
include, without limitation, the number of patients who
receive pembrolizumab or nivolumab that will have lasting clinical responses to
these agents; device
deficiencies or immediate complications; the possibility of novel treatment strategies; how the Hemopurifier may reduce tumor-derived
extracellular vesicles and enhance T cell activity against tumors; the efficacy
of continued clinical trials; development under IDE for indications; and/or the
number of patients enrolled in each cohort. 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 Executive Officer and Chief Financial
Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
Aethlon Medical Inc. (Nasdaq:AEMD) is
a featured biotech stock on Investorideas.com
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