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 leading investing news platform and biotech-stock research destination, 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.
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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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