Aethlon Medical Australia

Novel Immunotherapeutic Device to Combat Cancer and Life-Threatening Viral Infections

"We believe we are the first group to target the removal of extracellular vesicles as an investigational therapeutic strategy to improve outcomes in cancer, and that this strategy could also be applied potentially to a number on non-oncologic conditions.” Steven P. LaRosa, MD, Chief Medical Officer, Aethlon Medical and Director Aethlon Medical Australia Pty Ltd

About

Aethlon Medical Australia PTY LTD is a subsidiary of Aethlon Medical, dedicated to advancing innovative therapies for cancer and life-threatening infectious diseases. The company is focused on clinical research and development of the Hemopurifier®, an investigational extracorporeal medical device designed to remove harmful extracellular vesicles and viruses from the bloodstream-helping to overcome treatment resistance and improve patient outcomes. Through cutting-edge science the company aims to contribute to the future of immunotherapy and precision medicine.

In collaboration with leading medical institutions, Aethlon Medical Australia is conducting a safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumours who have stable or progressive disease during anti-PD-1 monotherapy treatment such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). Our initial focus is improving upon the 20-40% clinical response rates currently seen in patients with cancers including melanoma and non-small cell Lung Cancer (NSLC). Beyond oncology, extracellular vessicle removal holds promise as a potential therapeutic approach for other medical conditions.

Hemopurifier^®

Clinical trials are open for enrolment at Royal Adelaide Hospital, Pindara Private Hospital and GenesisCare/Royal North Shore Hospital. For more information and recruitment inquiries, contact Stephen P. LaRosa, MD at [email protected].

Description and Mechanism of Action:

The Aethlon Hemopurifier is an investigational extracorporeal medical device that incorporates plasma separation, size exclusion and affinity binding.

A plasma separator with fibres with a pore size of 200-500nm is filled externally to the fibres with a proprietary affinity resin containing the lectin Galanthus nivalis agglutinin (GNA) covalently bounds to a medical grade diatamacoeus earth.

GNA has an affinity to bi-mannose linkages found on the surfaces of extracellular vesicles and enveloped viruses.

Blood is pumped from the patient into the device where plasma is separated, viruses and extracellular vehicles (EVs) are removed, and then returned to the patient without the need for plasma replacement.

Clinical Experience with Aethlon Hemopurifier

One Oncology patient in Australia in the clinical trial has been treated and tolerated the 4-hour HP treatment without immediate complications. Read the story here...

The Aethlon Hemopurifier has been used in clinical trials or under Emergency Use conditions in 165 unique HP sessions in 39 patients.

The vast majority of these sessions have been in viral infections with 3 sessions occurring in 2 cancer patients.

The device has been well tolerated with specific risks mentioned in patient informed consent and monitored for in the clinical trial.

In a previous US study, a single patient with Head and Neck Cancer had decreased EV concentrations following each HP treatment

Rationale for Oncology Trial of Aethlon Hemopurifier

Immunotherapy with checkpoint inhibitor drugs such as the anti-PD-1 antibodies Pembrolizumab and Nivolumab have revolutionized the treatment of many solid tumours by reinvigorating the anti-tumour T cell response.

Despite the success of these agents, only 20-40% of patients will have a lasting clinical response.

EVs, nanoparticles with a lipid bilayer, released by cancer cells have been implicated in the “resistance” to these agents as well as to angiogenesis, metastases and chemotherapy resistance.

Decreases in EVs containing the CheckPoint PD-L1 have been associated with a response to anti-PD-1 agents and an improvement in anti-tumour T cell activity.

Blockade of Tumour-derived extracellular vesicles has been proposed as a therapeutic strategy in Oncology.

The Aethlon Hemopurifier has been designed to remove particles containing mannoses on their surface from circulation.

Extracellular vesicles from tumour cells are more likely to be mannosylated than EVs from non-tumour cells.

Aethlon has developed in vitro data and initial in vivo data supporting extracellular removal.

Australian Clinical Trial Description:

For complete description of the Clinical Trial please see: Brown, Met al. (2025). Protocol for a safety, feasibility, and dose-finding study of the Hemopurifier device in patients with solid tumours who have stable or progressive disease during pembrolizumab or nivolumab monotherapy. medRxiv. Access online here.

This clinical trial has been approved by the HREC and is open for enrolment at Royal Adelaide Hospital, Adelaide, South Australia; Pindara Private Hospital, Gold Coast, Queensland; and Genesis Care/Royal North Shore Hospital, Sydney, New South Wales.

Trial is specifically looking to screen patients who the treating oncologist has deemed to have either stable or progressive disease while on monotherapy with either Pembrolizumab or Nivolumab for solid malignancies.

The primary objective of the study is to assess the safety and feasibility of HP in the oncology population.

Additional goals are to determine how many HP treatments in a week are necessary to decrease EV numbers and improve anti-tumour T cell numbers and activity and the duration of these effects.

Potentially eligible patients who sign informed consent will undergo a screening visit to include history and physical exam, documentation of medical conditions and concomitant medications as well as screening bloodwork.

Patients who successfully pass screening will be enrolled into sequential cohorts to receive either 1, 2, or 3 Hemopurifier treatments during a one-week period.

3-6 patients will be enrolled in each cohort with the decision to advance from one cohort to the next made by an independent Data Safety Monitoring Board (DSMB).

For specific questions about the clinical trial, please email: [email protected]

Treatment with the Hemopurifier involves:

Placement of a double lumen vascular catheter by Interventional Radiology before the 1st HP treatment (usually day prior to 1st HP treatment).
Admission to outpatient dialysis area of investigative site for HP treatment.
Connection to Dialysis machine for the purpose of utilising the blood pump.
Priming of the device with saline
Administering full therapeutic dose unfractionated heparin for anticoagulation.
A 4hr period where blood will be pumped over the HP device. No fluid, solutes or plasma will be removed or replaced.
Blood samples will be obtained before, during and after treatment for safety as well as to assess EV numbers and T cell numbers and activity.
The patient will be monitored throughout the treatment with vital signs, continuous ECG and pulse oximetry, visual inspection of the HP and measurement of pressures on the dialysis machine.
The patient will be discharged home from the dialysis unit after the HP treatment when Point of Care (POC) Activated Clotting Time (ACT) measurement indicates that it is safe to do so.
The vascular catheter will be removed after the last HP treatment.
Patients will return for follow-up visits at 1,2,3,4 and 8 weeks post the last HP treatment to assess safety as well as to obtain follow-up EV and T cells labs.
Follow-up imaging will be done between 10 and 12 weeks after the last HP treatment.
Survival status will be obtained at 26- and 52-weeks post-treatment.

Connect

For specific questions about the clinical trial, please email: [email protected]

Additional Information on Aethlon Medical can be obtained at: www.aethlonmedical.com

Would you like to know more?

Marleau, A. M.,et al (2012). Exosome removal as a therapeutic adjuvant in cancer. Journal of Translational Medicine, 10, 134. Access online here.

Marleau, A. M., et al. (2020). Abstract 4509: Targeting tumor-derived exosomes using a lectin affinity hemofiltration device. Cancer Research, 80(16_Supplement), 4509. Access online here.

Amundson, D. E., et al. (2021). Removal of COVID-19 spike protein, whole virus, exosomes, and exosomal microRNAs by the Hemopurifier® lectin-affinity cartridge in critically ill patients with COVID-19 infection. Frontiers in Medicine, 8, 744141. Access online here.

Campion, R. de N.et al. (2025). A lectin affinity plasmapheresis device removes extracellular vesicles and microRNAs from renal perfusates following controlled oxygenated rewarming of discarded donor kidneys. Transplantation Reports, 10, 102215. Access online here.