Aethlon Medical has enroled the first patient in its Australian clinical trial evaluating the safety, feasibility, and optimal dosing of the Hemopurifier device in treating patients with solid tumours.
The trial will investigate the device’s potential to enhance responses to anti-PD-1 therapies such as Keytruda or Opdivo.
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Professor Michael Brown and his team enroled the first participant in the AEMD-2022-06 Hemopurifier Study at the Cancer Clinical Trials Unit at CALHN, Royal Adelaide Hospital.
After completing screening on 8 November, the patient will now undergo a two-month run-in period of anti-PD-1 therapy.
During this phase, measurements of extracellular vesicles and anti-tumour T-cell activity will take place.
Should there be no tumour improvement post-run-in, treatment with the Hemopurifier will ensue, with subsequent monitoring for extracellular vesicle concentration reductions and T-cell activity enhancements.
Aethlon Medical’s chief medical officer Steven LaRosa said: “Enrolment 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 thrilled with the pre-screening activity being done to identify patients at Royal Adelaide, as well as the second site, Pindara Private Hospital in the Gold Coast. This trial is our initial step in determining if the Hemopurifier treatment can improve upon the 30-40% response rates to anti-PD-1 therapies such as Opdivo and Keytruda.”
The device targets extracellular vesicles that contribute to cancer proliferation and resistance to anti-PD-1 treatments.
The ongoing trial will include approximately nine to 18 patients and will focus on adverse event incidences and safety laboratory test changes following treatment at various intervals after a two-month run-in with PD-1 antibody monotherapy.
Patients unresponsive to initial therapy can enter the Hemopurifier phase where they will receive up to three treatments within one week.
This study not only assesses safety but also seeks to determine the number of treatments necessary to decrease extracellular vesicle concentrations and whether these reductions can boost natural anti-tumour defences.
The findings from these exploratory analyses are expected to shape future efficacy and safety studies required for premarket approval by regulatory bodies.