Aethlon Medical's Hemopurifier Shows Positive Results in EV Removal Trial

Aethlon Medical has announced promising results for its Hemopurifier system from an in vitro binding study focused on the removal of extracellular vesicles (EVs) from plasma. The Hemopurifier is an advanced immunotherapeutic device currently in the clinical stage, designed to combat cancer, life-threatening viral infections, and to aid in organ transplantation procedures.

The Hemopurifier has received breakthrough device status from the US Food and Drug Administration (FDA) for treating advanced or metastatic cancer patients who do not respond to or cannot tolerate standard therapies. This designation extends to cancer types where exosomes contribute to the disease's progression or severity. Additionally, the device holds FDA breakthrough status and an open investigational device exemption (IDE) for addressing life-threatening viruses that lack approved treatments.

In human trials, the Hemopurifier has proven effective in eliminating life-threatening viruses. Pre-clinical studies have also shown its capability to remove harmful exosomes from biological fluids.

James Frakes, Aethlon Medical’s interim CEO and chief financial officer, highlighted the translational study's focus on assessing the removal of EVs and EVs with PD-L1 on their surface directly from plasma. Plasma samples were collected from patients undergoing anti-PD-1 antibody treatments through collaboration with an external laboratory. Aethlon Medical processed these samples using a scaled-down version of the Hemopurifier. The samples were then evaluated at Cellarcus Biosciences using vesicle flow cytometry techniques. The data analysis took place at NAMSA, Aethlon Medical’s chosen contract research organization (CRO) for an upcoming oncology study in Australia.

Frakes emphasized that the positive data from this in vitro study is a significant step forward for Aethlon Medical, particularly as they prepare for Phase 1 oncology trials in Australia and India. He noted that previous studies demonstrated the Hemopurifier's ability to reduce EVs when isolated from cancer patient plasma and placed in a buffer solution.

The translational study has produced pre-clinical evidence to support Aethlon Medical’s planned Phase 1 clinical trial. This trial aims to evaluate the safety, feasibility, and optimal dosage of the Hemopurifier in patients with solid tumors. It will include patients who exhibit stable or progressive disease while undergoing anti-PD-1 monotherapy treatments like Keytruda or Opdivo.

The Hemopurifier represents a significant innovation in the treatment of cancer and life-threatening viral infections. With its breakthrough device status and positive pre-clinical results, Aethlon Medical is poised to advance its clinical trials, potentially offering new hope to patients who have exhausted standard treatment options.