#Australia #Sydney #Aethlon Medical #Hemopurifier #cancer trial

Aethlon Medical's Significant Progress in Cancer Treatment

Aethlon Medical, Inc. (NASDAQ: AEMD), a pioneering medical technology company based in San Diego, is making notable strides in its clinical trial of the Hemopurifier®, a device aimed at treating patients with solid tumors not responding to anti-PD-1 therapies. This innovative approach could potentially reshape cancer treatments and improve outcomes for many patients.

Overview of the Hemopurifier® Clinical Trial

On June 18, 2025, Aethlon Medical announced a significant milestone: the successful treatment of the second patient in their Australian clinical trial at the Royal North Shore Hospital and the University of Sydney. This trial, which is set to explore the safety, feasibility, and dosing regimen of the Hemopurifier®, focuses on individuals whose cancers have stabilized or progressed despite ongoing treatment with anti-PD-1 monotherapy agents such as Keytruda® (pembrolizumab) and Opdivo® (nivolumab).

The second participant received treatment on June 11, 2025, following the first participant’s treatment at Royal Adelaide Hospital on January 29, 2025. Both patients completed their four-hour Hemopurifier sessions without any immediate complications or device deficiencies, which is a promising sign as they move forward in the study.

The Reaction of Key Personnel

Aethlon Medical's Chief Medical Officer, Dr. Steven LaRosa, expressed satisfaction regarding the tolerability of the treatment among the participants so far and anticipates further progress, including the enrollment of a third participant. This next step will activate a safety review by the Data Safety Monitoring Board (DSMB), an essential mechanism for evaluating the risk and progress of clinical trials.

Addressing a Critical Need

Current statistics indicate that only around 30-40% of patients treated with pembrolizumab or nivolumab experience a lasting response to these therapies. Tumor-derived extracellular vesicles (EVs) have been linked to the spread of cancer and resistance to standard treatments. By focusing on the removal of these EVs from the bloodstream, the Hemopurifier aims to enhance the body's ability to respond to anti-PD-1 antibodies, thus potentially improving therapeutic outcomes.

Preliminary preclinical studies have showcased the device's effectiveness in reducing the presence of exosomes in cancer patients’ plasma, substantiating the hypothesis that cleaving these vesicles can improve treatment results.

Trial Design and Future Directions

The ongoing trial will include about 18 patients and aims to identify the frequency of adverse events and any significant changes in safety laboratory tests among patients treated with the Hemopurifier. Prospective cohorts will receive a varying number of treatments and will be monitored extensively to determine the degree of EV concentration decrease and its subsequent effect on the efficacy of the body's immune response against cancer cells.

Planned analyses are set to disclose important insights that will inform the design of future studies, particularly an efficacy and safety evaluation required for regulatory approvals. The Hemopurifier also holds a Breakthrough Device designation from the FDA, emphasizing its potential in the cancer care landscape.

Conclusion

As Aethlon Medical continues its clinical trial efforts in Australia, the implications of the Hemopurifier could be profound, potentially changing the lives of countless cancer patients. With ongoing advancements, the company aims to cultivate new possibilities in cancer treatment and contribute significantly to oncology therapeutics. For more information on Aethlon Medical and its innovative device, visit AethlonMedical.com.

Forward-looking Statements

This article contains forward-looking statements within the meanings of federal securities laws, which are subject to risks and uncertainties, and actual outcomes may differ significantly from any future projections. Investors should review the Company’s annual report for risks that could impact these statements.