Skip to content
Aethlon Medical
Wara Samar

5th February 2025

Aethlon Medical Treats First Patient with Hemopurifier in Australia

Aethlon Medical has initiated its Australian clinical trial evaluating the Hemopurifier investigational device for cancer treatment, with the first patient receiving treatment at the Royal Adelaide Hospital. The trial aims to assess the feasibility and safety of the Hemopurifier in patients with solid tumours who exhibit stable or progressive disease while undergoing anti-programmed cell death protein 1 (PD-1) monotherapy. 

Study Overview and First Patient Treatment 

The dose-finding study is designed for individuals receiving PD-1 inhibitors, such as Nivolumab, and seeks to determine whether the Hemopurifier can enhance immune response by targeting extracellular vesicles (EVs) produced by tumours. The first subject, who had progressive disease following a two-month ‘run-in’ period of Nivolumab, underwent a four-hour Hemopurifier treatment administered by Professor Toby Coates and the dialysis team at the hospital. The procedure was well-tolerated, and follow-up safety visits were scheduled to monitor EV levels, anti-tumour T cell activity, and overall clinical response. 

The primary goal of the trial is to evaluate the incidence of adverse events and any clinically significant changes in safety laboratory tests. Patients who do not respond to PD-1 antibody monotherapy may receive up to three Hemopurifier treatments within a week. The study will also assess whether multiple treatments reduce EV concentration and enhance the body’s natural immune response against tumour cells. 

The Hemopurifier and Its Mechanism of Action 

The Hemopurifier is designed to bind and remove tumour-derived EVs from circulation, with preclinical studies demonstrating its ability to decrease exosome levels in cancer patients’ plasma. The device uses a combination of size exclusion, affinity binding, and plasma separation to eliminate both EVs and enveloped viruses from the bloodstream. 

The US Food and Drug Administration (FDA) has granted the Hemopurifier breakthrough device designation, and it is currently being evaluated under an open investigational device exemption (IDE) application for use against life-threatening viruses that lack approved treatments. In November 2024, Aethlon Medical enrolled the first patient in the Australian trial to explore the device’s feasibility, optimal dosing, and safety in the treatment of solid tumours. 

As the study progresses, data from the initial treatment cohort will provide insights into the Hemopurifier’s potential to reduce tumour-derived EVs and support anti-tumour T cell activity. The findings may contribute to the development of new therapeutic approaches for patients with advanced solid tumours who have limited response to existing treatments. 

MedTech World Dubai: Nominations Now Open  

Do you have an innovative MedTech idea, or do you know someone who does? Now is the time to nominate for the MedTech World Awards! With 21 categories celebrating excellence in the field, MedTech World Dubai will take place on February 23 and 24. Don’t miss the opportunity to recognize groundbreaking contributions—submit your nomination today!

MedTech Dubai 2025