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Advancing Into the Next Phase: Aethlon Medical's Hemopurifier Clinical Trials

Aethlon Medical, Inc. (Nasdaq: AEMD), a biotechnology company in the clinical stage, has announced significant progress in its ongoing clinical trial of the Aethlon Hemopurifier® device. On July 15, 2025, the company declared that an independent Data Safety Monitoring Board (DSMB) conducted a thorough review of the safety data and recommended advancing to the next cohort of patients without any modifications.

The current trial, designated AEMD-2022-06, is exploring the safety, feasibility, and optimal dosing of the Hemopurifier in patients suffering from solid tumors. This is particularly crucial for those enduring either stable or progressive disease while undergoing treatment regimens that contain Pembrolizumab or Nivolumab. During their review, the DSMB evaluated the results from the initial subgroup of three participants, each of whom underwent a single 4-hour treatment session with the device.

Importantly, the DSMB reported no safety concerns arising from the treatments, which reinforces the favorable safety profile observed in this context. Dr. Steven LaRosa, Aethlon Medical's Chief Medical Officer, expressed optimism regarding the findings, highlighting the study as a pivotal moment in the comprehensive clinical development of the Hemopurifier for oncology applications. This advancement is vital considering the significant unmet medical need present for the 60-70% of cancer patients who do not show a durable clinical response to established anti-PD-1 immunotherapies.

Next Steps in the Clinical Trial

With the positive recommendation in hand, Aethlon Medical is set to open enrollment for the second cohort. Participants in this phase will be administered two Hemopurifier treatments over a one-week timeline, taking place across three active clinical sites based in Australia. The trial aims to recruit between 9 to 18 patients who fit the criteria. This aspect of the trial is designed to further delve into the safety and feasibility of employing the Hemopurifier in this patient population, exploring varying dosing intervals amid ongoing cancer treatments that allow agents like Pembrolizumab, marketed as Keytruda®, or Nivolumab, known as Opdivo®.

The primary goal of this trial iteration includes gauging the incidence of adverse events alongside clinically significant changes as evaluated through safety laboratory tests in patients treated with the Hemopurifier. In addition to these safety measures, researchers will analyze the frequency of Hemopurifier treatments needed to potentially lower the levels of extracellular vesicles (EVs) in circulation, with the underlying hypothesis that a reduction in EV concentrations could improve the immune system's natural capacity to counteract cancer cells.

About the Hemopurifier

The Hemopurifier is an investigational device meticulously designed to extricate enveloped viruses and tumor-derived extracellular vesicles from the bloodstream. Utilizing a blood pump, it operates extracorporeally, leveraging plasma separation, size exclusion, and affinity binding through a plant lectin resin that specifically targets the mannose-rich surfaces characteristic of both EVs and viruses. It is believed that EVs, especially those released by solid tumors, play a pivotal role in metastasis and resistance to both immunotherapy and chemotherapy agents. Previous in vitro studies, alongside human subject trials, have confirmed the device’s capacity for effectively removing these unwanted entities.

Currently, the Hemopurifier carries a U.S. Food and Drug Administration Breakthrough Device designation for two primary indications: treating individuals with advanced or metastatic cancer that do not respond to standard care therapies, and the treatment of life-threatening viral infections not manageable through existing therapies. The device is under active development through an open Investigational Device Exemption (IDE) authorized for both categories of usage.

Commitment to Advancement

Aethlon Medical, Inc. remains dedicated to advancing the Hemopurifier, affirming its potential in addressing critical needs in the fields of oncology and infectious diseases. The company pledges continuous updates as the clinical trial develops further. For more information, perspectives, and insights, interested readers can visit Aethlon Medical's website and remain attuned to their latest news through platforms like LinkedIn.

Conclusion

The advancement to the next cohort reflects a collaborative effort between Aethlon Medical, clinical experts, and patients who are enduring challenging cancer diagnoses. As they continue to navigate this trial process, they edge closer to finding viable solutions that could revolutionize treatment pathways for those who have limited options left. This underlines the importance of rigorous clinical trials in identifying innovative therapies that can significantly improve patient outcomes in the realm of cancer care.