Aethlon Medical Continues to Observe Directional Changes in Second Cohort of Australian Oncology Clinical Trial Evaluating Hemopurifier®
Rhea-AI Summary
Aethlon Medical (Nasdaq: AEMD) reported that patients in the second cohort of its Australian oncology feasibility study of the investigational Hemopurifier showed biological changes similar to those seen in the first cohort after treatment. Replicating these biomarker shifts supports continued enrollment of the third and final cohort, after which an independent statistician will analyze combined data for potential dose-response patterns.
The study evaluates safety, feasibility and dosing of Hemopurifier in patients with advanced solid tumors progressing despite anti-PD-1 immunotherapies. Observed changes include reductions in several extracellular vesicle populations and tumor-associated microRNAs, improvements in multiple immune-related laboratory ratios, and increases in total and tumor-specific T-cell populations. Aethlon highlights that these are preliminary, descriptive observations from an early-stage feasibility study, not designed to demonstrate clinical efficacy, and that larger, adequately powered trials will be needed to assess clinical benefit.
Positive
- Consistent biomarker changes in two cohorts observed after Hemopurifier treatment in advanced solid tumor patients
- Second cohort showed more consistent and persistent reductions in multiple extracellular vesicle types through eight-week follow-up
- Immune-related ratios such as NLR, MLR, SII, MAR and LAI shifted in directions associated in literature with improved immunotherapy responses
- T-cell populations including CD4, CD8 and CD137-positive tumor-specific T cells increased in all three second-cohort participants
- Third cohort enrollment underway with the first participant completing three four-hour Hemopurifier sessions in one week
- FDA Breakthrough Device Designation granted for advanced/metastatic cancer unresponsive to standard therapy and for certain life-threatening viral infections
Negative
- Data remain preliminary, based only on descriptive observations from an early-stage feasibility study
- No formal statistical analysis yet; independent statistician will assess only after all three cohorts are completed
- Study not powered for efficacy, so no conclusions can be drawn about Hemopurifier’s impact on clinical outcomes
- Small sample size to date, with biomarker findings limited to early cohorts in a feasibility setting
- Future larger trials required with clinical efficacy endpoints before any potential clinical benefit can be established
News Explained
The third cohort is underway, but the release still provides no completed statistical analysis or clinical-efficacy result.
The
The study is evaluating the Hemopurifier’s safety, feasibility, and dosing in patients with advanced solid tumors whose cancers progressed despite anti-PD-1 treatment. Although Aethlon says the repeated observations strengthen the scientific rationale, the release describes them as preliminary, descriptive observations from raw data; formal statistical analysis has not yet been performed, and the study was not designed to demonstrate clinical efficacy.
The stated next milestones are completion of all three cohorts, analysis of the combined data by an independent statistician, and later larger trials using clinical-efficacy endpoints.
Market reaction: AEMD -5.51% on Australian oncology feasibility trial update
On the day this news was published, AEMD declined 5.51%, reflecting a notable negative market reaction. Argus tracked a peak move of +5.3% during that session. Argus tracked a trough of -6.7% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $109K from the company's valuation, bringing the market cap to $1.86M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 24 | DSMB safety review | Positive | -6.1% | DSMB found no safety concerns and recommended advancing to final cohort. |
| Oct 08 | Early cohort data | Neutral | +4.0% | Early observations from first three oncology patients showed directional EV and microRNA changes. |
| Oct 07 | Cohort 1 biomarker data | Neutral | -5.8% | Preliminary Hemopurifier biomarker shifts reported in first cohort with extensive caveats. |
| Jul 15 | DSMB review cohort 1 | Positive | +4.3% | DSMB saw no safety issues in initial cohort and recommended advancing to cohort 2. |
| May 14 | Preclinical EV removal data | Positive | -2.3% | Preclinical data showed strong removal of platelet-derived EVs supporting oncology trial rationale. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
For prior clinical-trial updates, Aethlon’s share-price reaction has been mixed, with several positive safety or biomarker updates followed by flat-to-negative next-day moves on average.
Key Terms
extracellular vesicles medical
micrornas medical
neutrophil-to-lymphocyte ratio medical
systemic immune-inflammation index medical
pd-l1 medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Second cohort findings consistent with previously reported observations; independent statistical analysis planned following completion of all three patient cohorts
"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® 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® and Opdivo®. The Hemopurifier® 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® and Opdivo®. 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.
About Aethlon Medical
Aethlon Medical, Inc. is developing the Hemopurifier®, 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® 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 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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SOURCE Aethlon Medical, Inc.