Medical therapeutic company Aethlon Medical has announced the treatment of the first patient using the Aethlon Hemopurifier in its Australian safety, feasibility, and dose-finding study.

The Aethlon Hemopurifier is an investigational extracorporeal device designed to remove enveloped viruses and tumour-derived extracellular vesicles (EVs) from the bloodstream.  

This trial focuses on patients with solid tumours having stable or progressive disease during anti-PD-1 monotherapy treatment, like Keytruda (pembrolizumab) or Opdivo (nivolumab).

The patient was enrolled in late October 2024 at the Royal Adelaide Hospital in Australia.

The individual, who showed progressive disease after a two-month nivolumab ‘run-in’ period, underwent treatment with the Aethlon Hemopurifier for four hours.

During the run-in period, measurements of EVs and anti-tumour T cell activity were taken.

The patient tolerated the Hemopurifier procedure without complications and will have follow-up visits for safety monitoring, EV and T cell measurements, and imaging to assess clinical response.

The primary endpoint of the trial, which will involve around 18 patients, is to assess the incidence of adverse events and any clinically significant changes in safety laboratory tests for patients treated with the Hemopurifier.

These patients must have solid tumours with either stable or progressive disease after a two-month run-in period of PD-1 antibody monotherapy.

Patients who do not respond to monotherapy will enter the Hemopurifier treatment phase, where sequential cohorts will receive one, two, or three treatments during a one-week period.

The study will also monitor the effects of the Hemopurifier on EV concentrations and explore how changes in EV levels may enhance the body’s ability to target tumour cells.

These findings will inform the design of a future premarket approval (PMA) study for regulatory review.

Aethlon Medical chief medical officer Steven LaRosa said: “Treatment of the first patient represents the achievement of a critical milestone for Aethlon Medical in the clinical development of the Hemopurifier in Oncology.

“We are excited to receive the data from this first treatment cohort, anticipating insights into how the Hemopurifier may reduce tumour-derived extracellular vesicles and enhance T cell activity against tumours.”

The Aethlon Hemopurifier works with a blood pump and utilises plasma separation, size exclusion, and affinity binding with a plant-derived lectin resin.  

The Hemopurifier has shown effectiveness in removing viruses and EVs in both in vitro and human studies.

It has received the US Food and Drug Administration (FDA) breakthrough device designation for treating advanced or metastatic cancer patients. Additionally, it holds an open investigational device exemption (IDE) for treating life-threatening viruses that lack approved therapies.