SAN DIEGO, California, July 13, 2026
Aethlon Medical, Inc. has announced encouraging interim findings from the second patient cohort of its ongoing Australian oncology feasibility clinical trial evaluating the investigational Hemopurifier® in patients with advanced solid tumors who have progressed despite treatment with anti-PD-1 immunotherapies. The latest results demonstrated consistent directional biological changes that closely mirrored those observed in the first cohort, strengthening the scientific rationale for the company’s innovative immunotherapy approach. The study is designed to assess the safety, feasibility, dosing, and biological activity of the Hemopurifier, a novel extracorporeal therapeutic intended to remove tumor-derived extracellular vesicles (EVs) and other disease-promoting particles from the bloodstream. With enrollment now underway in the third and final patient cohort, Aethlon plans to conduct an independent statistical analysis after completion of all participants to determine whether the observed biological changes support a meaningful dose-response relationship. Although the findings remain preliminary, the replicated biomarker trends provide additional support for continued clinical development of the technology in oncology.
Second Patient Cohort Reinforces Early Clinical Findings
The second cohort demonstrated several encouraging biological changes following Hemopurifier® treatment, including sustained reductions in tumor-derived extracellular vesicles (EVs), platelet-derived EVs, and PD-L1-positive EVs, which are increasingly recognized as contributors to tumor progression and resistance to immunotherapy. Researchers also observed decreases in two microRNAs associated with tumor invasion and cancer progression, alongside improvements in multiple immune-inflammatory biomarkers, including the 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). These laboratory markers have previously been linked with improved responses to immune checkpoint inhibitors in published cancer research. In addition, all participants demonstrated increases in CD4-positive T cells, CD8-positive T cells, total T-cell populations, and tumor-specific CD137-positive T cells, with these immune responses persisting throughout the eight-week follow-up period.
Novel Device Targets Tumor-Derived Extracellular Vesicles
Unlike traditional cancer therapies, the Hemopurifier® is designed to physically remove tumor-derived extracellular vesicles from circulation. These microscopic vesicles play an important role in promoting immune suppression, facilitating tumor growth, encouraging metastasis, and reducing the effectiveness of immune checkpoint inhibitors such as anti-PD-1 therapies. By reducing these circulating immunosuppressive particles, researchers believe the device may improve the body’s natural immune response against cancer while potentially enhancing the effectiveness of existing immunotherapy treatments. The investigational device has already received FDA Breakthrough Device Designation for patients with advanced or metastatic cancer who have exhausted standard treatment options, as well as for certain life-threatening viral infections, highlighting its potential as a versatile therapeutic platform.
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Third Cohort Enrollment Continues Toward Independent Analysis
Following the encouraging consistency observed across the first two patient cohorts, Aethlon Medical has begun enrolling participants into the third and final cohort, with the first patient already completing three four-hour Hemopurifier treatment sessions during a one-week treatment period. After enrollment is complete, an independent statistician will evaluate the combined dataset to determine whether the biological trends represent a statistically meaningful treatment effect and potential dose-response relationship. The company emphasized that the current feasibility study was not designed to demonstrate clinical efficacy and that larger, adequately powered clinical trials will be required to determine whether the observed biomarker improvements translate into meaningful patient outcomes. Nevertheless, the repeated biological responses observed across multiple participants reinforce the scientific foundation supporting Hemopurifier’s continued clinical evaluation as a novel adjunctive therapy in advanced oncology, while also highlighting its broader potential across cancer immunotherapy, infectious diseases, and future emerging health threats.
Source: Aethlon Medical press release
