Aethlon Medical (Nasdaq: $AEMD)
Reports Consistent Directional Changes in Second Cohort of Australian
Hemopurifier Oncology Trial
Second
cohort findings consistent with previously reported observations; an
independent statistical analysis is planned following completion of all three
patient cohorts
Investorideas.com (www.investorideas.com newswire), a
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features clinical-stage medical technology company and Investorideas.com
featured stock Aethlon Medical, Inc. (Nasdaq: AEMD).
Aethlon Medical, Inc. (Nasdaq: AEMD), a medical
therapeutic company developing products to treat cancer and life-threatening
viral infections, today announced that patients in the second cohort of its Australian
oncology feasibility study demonstrated biological changes consistent with
those previously observed in the first cohort following treatment with the
investigational Hemopurifier(R). Replicating these findings in a second group
of patients strengthens the scientific rationale for the Company's ongoing
clinical program and supports continued enrollment in the third and final
cohort before an independent statistical analysis is conducted.
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"We
are encouraged to observe similar directional changes across multiple
biomarkers in both the first and second patient cohorts," said James
Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical.
"Observing these directional changes in a second patient cohort builds
upon our initial observations and provides additional data as we advance toward
completion of the third cohort. While these are preliminary findings from an
early feasibility study, they represent an important milestone as we advance
toward completion of the third cohort and an independent statistical analysis
to determine whether these observations represent a dose-response to
Hemopurifier treatment."
The
Australian feasibility study is evaluating the safety, feasibility and dosing
of the Hemopurifier(R) in patients with advanced solid tumors whose cancers
have progressed despite treatment with anti-PD-1 immunotherapies.
The
second cohort continued to show directional changes in several biomarkers that
researchers believe are associated with tumor growth, immune suppression and
response to immunotherapy, including:
Reductions
in tumor-derived extracellular vesicles (EVs), platelet-derived EVs and
PD-L1-positive EVs, with these changes appearing more consistently across all
participants than in the first cohort and generally persisting through the
eight-week follow-up period.
Reductions
in two microRNAs that have been associated with tumor growth and cancer
invasion.
Improvements
in multiple immune-related laboratory ratios - including
neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR),
Systemic Immune-Inflammation Index (SII), monocyte-to-albumin ratio (MAR) and
Lymphocyte Albumin Index (LAI) - that have been associated in published
research with improved responses to immunotherapy.
Increases
in total T cells, CD4 and CD8 T-cell populations, and tumor-specific
CD137-positive T cells in all three participants, with these changes generally
persisting through the eight-week follow-up period.
Taken
together, the first two cohorts have now shown similar directional changes
across multiple biological markers following Hemopurifier treatment. Enrollment
in the third cohort is underway, with the first participant having already completed
three four-hour Hemopurifier treatments during a one-week period. After all
three cohorts are complete, an independent statistician will analyze the
combined data to determine whether these observations support a dose-response
relationship.
EVs continue
to be recognized as important drivers of cancer progression and resistance to
checkpoint inhibitors such as Keytruda(R) and Opdivo(R). The Hemopurifier(R) is
designed to remove these tumor-derived vesicles from the bloodstream, with the
goal of reducing immune suppression and potentially enhancing the body's
ability to fight cancer.
"We
believe the Hemopurifier has the ability to complement existing therapies
rather than replace them and could be a platform technology with potential
applications across multiple disease areas such as oncology, infectious
diseases, and future emerging threats. We believe there exists a 'pipeline
within a single device,'" said Mr. Frakes.
Advancing a Novel Approach to Cancer
Immunotherapy
Extracellular
vesicles released by tumors continue to be recognized as important drivers of
cancer progression, metastasis and resistance to immunotherapy. EVs expressing
PD-L1 have been associated with resistance to checkpoint inhibitors, including
Keytruda(R) and Opdivo(R). The Hemopurifier is designed to remove tumor-derived
EVs and other pathogenic particles from circulation, potentially reducing
immunosuppressive signaling and improving the body's anti-tumor immune
response.
The
Hemopurifier has received FDA Breakthrough Device Designation for the treatment
of patients with advanced or metastatic cancer who are unresponsive or
intolerant to standard-of-care therapy, as well as for the treatment of
life-threatening viral infections not addressed by approved therapies.
Important
Study Limitations
The
Company cautions that these findings represent descriptive observations from
raw data generated in an early-stage feasibility study. Formal statistical
analyses have not yet been performed and will be conducted only after
completion of all three study cohorts by an independent statistician.
The
study was not designed to demonstrate clinical efficacy, and no conclusions can
be drawn regarding the Hemopurifier's impact on patient outcomes. Larger,
adequately powered clinical trials designed with clinical efficacy endpoints
will be required to determine whether the biological changes observed translate
into meaningful clinical benefit.
Aethlon Medical, Inc. (Nasdaq: AEMD) is a featured
biotech stock on Investorideas.com
More
info on AEMD at Investorideas.com Visit: https://www.investorideas.com/CO/AEMD/
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News Alerts on Aethlon Medical
About Aethlon
Medical
Aethlon
Medical, Inc. is developing the Hemopurifier(R), an investigational
extracorporeal therapeutic designed to remove tumor-derived extracellular
vesicles and enveloped viruses from the bloodstream. The Company is advancing
the Hemopurifier in oncology and life-threatening viral infections with the
goal of improving outcomes for patients with limited treatment options.
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 include but are not limited to
statements regarding the completion and timing of enrollment in the third
cohort of the Australian oncology feasibility study; the timing and results of
the independent statistical analysis; whether the biological changes observed
following Hemopurifier(R) treatment are reproducible or support a dose-response
relationship; the potential safety, feasibility or biological activity of the
Hemopurifier; the ability of the Hemopurifier to remove tumor-derived
extracellular vesicles or otherwise modulate immune function; whether the
biological changes observed will translate into meaningful clinical benefit or
improved patient outcomes; the potential for the Hemopurifier to complement
existing cancer therapies or improve responses to immunotherapy; the future
development, regulatory progress, clinical evaluation, commercialization or
market acceptance of the Hemopurifier; the potential applicability of the
Hemopurifier in oncology, viral infections or other disease indications; and
the Company's plans, expectations and objectives for future clinical studies
and development activities. 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.
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, 2026, 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 clinical findings
described herein are preliminary in nature, have not been subjected to formal
statistical analysis, and may not be replicated in subsequent clinical studies
or 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
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