Core Insights - Aethlon Medical has achieved a significant milestone by treating the second patient with the Hemopurifier in its clinical trial for solid tumors not responding to anti-PD-1 antibodies [1][2] - The trial aims to assess the safety and feasibility of the Hemopurifier, with the first cohort consisting of approximately 18 patients [6] - The Hemopurifier is designed to remove tumor-derived extracellular vesicles (EVs) from the bloodstream, potentially improving responses to anti-PD-1 therapies [5][7] Group 1: Clinical Trial Progress - The second patient was treated on June 11, 2025, at the Royal North Shore Hospital/University of Sydney, following the first patient treated on January 29, 2025 [1][2] - Both patients completed the 4-hour Hemopurifier treatment without device deficiencies or immediate complications, and have finished the 7-day safety follow-up period [2][4] - The Data Safety Monitoring Board (DSMB) will review the safety data after the third patient is enrolled, which is expected to occur soon [3][4] Group 2: Device and Mechanism - The Hemopurifier is an investigational device that utilizes plasma separation and affinity binding to remove enveloped viruses and EVs from circulation [7][8] - Preclinical studies indicate that the Hemopurifier can reduce the number of exosomes in cancer patient plasma, which may enhance the effectiveness of anti-PD-1 therapies [5][6] - The device holds FDA Breakthrough Device designation for treating advanced or metastatic cancer patients who are unresponsive to standard therapies [8] Group 3: Future Directions - The primary endpoint of the trial is to monitor adverse events and significant changes in safety lab tests among treated patients [6] - The study will also explore the number of Hemopurifier treatments required to decrease EV concentrations and whether this improves the immune response against tumor cells [6] - Data on the effects of the Hemopurifier on anti-tumor T cell activity is anticipated approximately three months after the enrollment of the third patient [3]

Core Insights - Aethlon Medical, Inc. announced the publication of a pre-clinical ex vivo study demonstrating the effectiveness of its Hemopurifier in removing platelet-derived extracellular vesicles (PD-EVs) from plasma, which supports ongoing oncology clinical trials in Australia [1][4][6] Group 1: Study Findings - The study showed a 98.5% removal of PD-EVs from 200 milliliters of healthy human plasma, simulating a 4-hour treatment session with the Hemopurifier [3][4] - The results indicate the potential of the Hemopurifier to address various diseases where PD-EVs are implicated, including cancer and other serious conditions [5][6] Group 2: Clinical Implications - The findings are expected to enhance the ongoing oncology clinical trial in Australia, where the focus will be on PD-EV removal in enrolled subjects [4][5] - The Hemopurifier is recognized as a Breakthrough Device by the FDA, aimed at treating advanced or metastatic cancer and life-threatening viral infections [6] Group 3: Future Directions - The company plans to submit the study findings for peer review and further investigate PD-EV removal in plasma samples from various diseases [5] - There is potential for the Hemopurifier to serve multiple therapeutic indications beyond oncology, suggesting a "pipeline within a device" concept [5]