US-based Aethlon Medical has treated the first subject with its Hemopurifier investigational device in its Australian cancer trial.
Designed for subjects with solid tumours, the dose-finding trial aims to evaluate the feasibility and safety of the Hemopurifier for patients with stable or progressive disease during anti-programmed cell death protein 1 (PD-1) monotherapy treatment.
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Treated at Royal Adelaide Hospital by Professor Toby Coates and the dialysis team, the patient had progressive disease following a two-month ‘run-in’ period of Nivolumab, an anti-PD-1 drug.
Treatment with Hemopurifier, which lasted four hours, was well-tolerated, and follow-up safety visits were scheduled to monitor extracellular vesicles (EVs), anti-tumour T cell activity, and clinical response.
Aethlon 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 primary endpoint is to assess the incidence of adverse events and any clinically significant changes in safety lab tests of the device in subjects with solid tumours and stable or progressive disease.
Subjects unresponsive to PD-1 antibody monotherapy may receive one to three Hemopurifier treatments over a week.
The study will also investigate the number of treatments required to reduce EV concentration and whether this leads to an enhanced natural immune response against tumour cells.
The Hemopurifier is tailored to bind and remove tumour-produced EVs from the bloodstream. Preclinical studies have shown the device’s ability to decrease exosomes in cancer patients’ plasma.
It employs size exclusion, affinity binding, and plasma separation to eliminate enveloped viruses and EVs from circulation.
Hemopurifier received breakthrough device designation from the US Food and Drug Administration (FDA) and is subject to an open investigational device exemption (IDE) application for treating life-threatening viruses without approved therapies.
In November 2024, Aethlon Medical enrolled the first subject in the Australian clinical trial to evaluate the feasibility, optimal dosing, and safety of the Hemopurifier for treating solid tumours.
