Medical
Tech Stock Aethlon Medical, Inc. (NASDAQ: $AEMD)
Advances to Final Cohort in Oncology
Clinical Trial Following Positive DSMB Review
(Investorideas.com
Newswire) Investorideas.com, a leading investment platform for retail investors
reports breaking Medical Tech Stock news for
Aethlon
Medical, Inc. (Nasdaq: AEMD),
a medical
therapeutic company focused on developing products to treat cancer and
life-threatening infectious diseases.
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 of the
second cohort participant data and recommended advancing to the third and final
cohort. They also stated that “no safety concerns were noted with Hemopurifier
device/procedure”.
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- comprised
of independent medical experts in nephrology and oncology- reviewed data from participants
enrolled in the second cohort, in which patients received two Hemopurifier
treatments over a one-week period. Based
on their evaluation, the DSMB 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 device or treatment have been reported.
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"The DSMB's continued
positive recommendation supports the safety profile observed to date and allows
us to advance into the third and final cohort of this study,” said Steven
LaRosa, M.D, Chief Medical Officer of Aethlon Medical. "We are encouraged
by the gathering momentum of the trial and having a final data set and clinical
study report to share with potential investors, partners and regulatory
agencies”.
Enrollment for Cohort
3 is now open. In this final cohort, participants will receive three Hemopurifier
treatments over a one-week period further evaluating safety, feasibility and
dosing parameters at the study’s three active clinical sites in Australia. This
trial is designed to enroll approximately 9 to 18-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 extracellular
vesicles (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 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. Forward-looking statements in this press release include but are not limited to statements
regarding advancement and completion of the Company’s clinical trial; patient
enrollment and timing; the safety, tolerability and dosing of the Hemopurifier;
the potential biological or clinical effects of the Hemopurifier; the ability
of the study to inform future trials; and the Company’s development plans,
regulatory pathway and potential applications of the Hemopurifier. 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. The findings
described herein are preliminary in nature, have not been peer-reviewed, and
may not be replicated in subsequent studies or clinical trials.
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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