Aethlon Medical has achieved significant clinical milestones in its Hemopurifier cancer trial, successfully treating the first three patients at Australian sites while expanding its global regulatory footprint with approval to initiate trials in India. The company's innovative extracellular vesicle removal technology demonstrated promising preclinical results and is being investigated for broader therapeutic applications including Long COVID.
Clinical Trial Progress in Australia
Aethlon completed Hemopurifier treatments in the first three participants enrolled in its safety, feasibility, and dose-finding study of patients with solid tumors unresponsive to anti-PD-1 agents. Participant #1 was treated at Royal Adelaide Hospital in January 2025, while Participants #2 and #3 received treatment at Royal North Shore Hospital in Sydney in June 2025. All participants completed a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications and have completed the pre-specified 7-day safety follow-up.
This milestone triggers the first meeting of an independent Data Safety Monitoring Board (DSMB) to review safety data and recommend advancement to the second treatment cohort. In the next cohort, participants will receive two Hemopurifier treatments during a one-week period. Preliminary data from the first cohort, including effects on extracellular vesicle (EV) removal and anti-tumor T-cell activity, are expected in approximately three months.
The primary endpoint for the approximate 9 to 18-patient study is safety. The trials will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals. Sequential cohorts will receive 1, 2, or 3 Hemopurifier treatments during a one-week period.
Expanded Treatment Protocol and Regulatory Approval
The trial protocol was amended to broaden eligibility to include patients receiving combination therapies with Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®), in line with current treatment practices. Currently, only about 30% of patients receiving pembrolizumab or nivolumab experience lasting clinical responses. EVs released by tumors have been implicated in cancer progression and resistance to anti-PD-1 therapies.
On June 19, 2025, the company received formal approval from India's Central Drugs Standard Control Organization (CDSCO) to initiate a similar trial at Medanta Medicity Hospital. The approval followed a meeting with the Subject Expert Committee and prior Ethics Committee clearance. The trial will begin following a Site Initiation Visit conducted by Aethlon's India-based CRO, Qualtran.
Preclinical Data Supports Broader Applications
Results from Aethlon's preclinical ex vivo study, published in bioRxiv on May 12, 2025, showed that the Hemopurifier, using proprietary Galanthus nivalis agglutin (GNA) affinity resin, removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) from human plasma during a timepoint equivalent to a 4-hour treatment. Excessive levels of PD-EVs have been implicated in multiple diseases, including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, acute and Long COVID.
Long COVID Research Collaboration
Aethlon's collaborative research with the UCSF Long COVID Clinic was accepted for a poster presentation at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes (August 10-13, 2025). The study analyzed blood samples from participants with Long COVID as well as controls that had recovered from COVID-19 infection to evaluate the binding of extracellular vesicles to the Hemopurifier's lectin affinity resin. Long COVID represents an unmet medical need affecting approximately 44 to 48 million people in the United States alone, with an estimated economic burden of $2 billion in those with symptoms lasting a year.
Device Technology and FDA Status
The Hemopurifier is designed to bind and remove EVs from the bloodstream, potentially improving therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples. The device is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses.
Financial Position and Operational Efficiency
As of March 31, 2025, Aethlon had a cash balance of approximately $5.5 million. The company significantly reduced its operating expenses to $9.3 million for fiscal year 2025, representing a decrease of $3.3 million or approximately 26% compared to $12.6 million for fiscal year 2024. This reduction was primarily driven by lower payroll and related expenses, professional fees, and general and administrative costs, positioning the company for sustained focus on its clinical and regulatory goals.
