Aethlon Medical has reported positive results for its Hemopurifier system in an in vitro binding study in removing extracellular vesicles (EVs) from plasma.
Hemopurifier is a clinical stage immunotherapeutic device designed to fight cancer and life-threatening viral infections. It is also aimed to be used during organ transplantation.
The system has received breakthrough device status from the US Food and Drug Administration (FDA) to treat those with advanced or metastatic cancer who either do not respond to or cannot tolerate standard therapy.
It also has the same designation for cancer types where exosomes support disease progression or severity.
Additionally, the Hemopurifier device has FDA breakthrough status and an open investigational device exemption (IDE) application for addressing life-threatening viruses lacking approved therapies.
In human studies, the Hemopurifier has shown effectiveness in eliminating life-threatening viruses.
It has also demonstrated its ability to remove detrimental exosomes from biological fluids in pre-clinical trials.
According to Aethlon Medical interim CEO and chief financial officer James Frakes, the robust translational study specifically assessed the removal of EVs and EVs with PD-L1 on their surface directly from plasma.
The samples were obtained from patients undergoing anti-PD-1 antibody treatment through collaboration with a third-party lab.
Aethlon Medical processed the plasma samples using a miniature version of the Hemopurifier.
Subsequently, the samples went for evaluation at Cellarcus Biosciences using Vesicle flow cytometry methodology.
The data was then analysed at NAMSA, the medical therapeutic company’s chosen contract research organisation (CRO) for the planned Australian oncology study.
Frakes said: “The positive data from this in vitro binding study of the Hemopurifier is an important step forward for Aethlon, ahead of the potential start of our planned Phase 1 oncology trials in Australia and India.
“We have previously demonstrated that our Hemopurifier can reduce EVs isolated from cancer patient plasma when those EVs are placed in a buffer solution.”
The translational study has generated pre-clinical evidence to back Aethlon Medical’s forthcoming Phase 1 clinical trial.
The Phase 1 study is intended to assess the safety, feasibility, and dosage determination of the Hemopurifier in patients with solid tumors.
It will assess patients who have stable or progressive disease while undergoing anti-PD-1 monotherapy therapies like Keytruda or Opdivo.
