US-based medical therapeutic company Aethlon Medical has received full ethics approval from the Bellberry Human Research Ethics Committee (BHREC) for a clinical trial of the Hemopurifier in patients with solid tumours.
The AEMD-2022-06 Hemopurifier Study aims to evaluate the safety, feasibility and optimal dosing of the Hemopurifier in patients experiencing stable or progressive disease while receiving anti-PD-1 monotherapy treatments.
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Aethlon Medical’s Hemopurifier is designed to capture and eliminate tumour-produced extracellular vesicles from the blood, where they are thought to cause resistance to solid tumour therapies and cancer proliferation.
Preclinical studies have demonstrated the drug’s ability to reduce exosome levels in the plasma of cancer patients.
The trial is due to take place at Pindara Private Hospital in Queensland, Australia, with the primary aim of assessing the Hemopurifier’s safety.
It will also monitor adverse events and significant laboratory changes in patients with solid tumours who have stable or progressive disease after a two-month period of PD-1 antibody therapy with Keytruda or Opdivo.
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By GlobalDataEligible patients who do not respond to PD-1 therapy will proceed to the Hemopurifier phase, in which cohorts will undergo one to three Hemopurifier treatments over a week.
The trial will assess the number of treatments required to lower EV concentrations and whether a reduction in concentration can boost the body’s natural defences against tumour cells.
The approval from the ethics committee is valid until 6 August next year.
Aethlon Medical chief medical officer Steven LaRosa said: “We are quite pleased that the BHREC accepted our responses to their thoughtful questions during their review and determined that our study meets the requirements of the National Statement application.
“This is the second ethics committee approval we have received for our oncology trial in Australia after receiving approval from the ethics committee for Royal Adelaide Hospital in June.”
