Company: AEMD
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001683168-25-006049
Chunk: 6

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-13
Form: 10-Q
Item: Item 1
Chunk 6
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41 patients), the Hemopurifier was used safely and demonstrated the potential to remove enveloped viruses.
In pre-clinical studies, the Hemopurifier has exhibited the capacity to remove harmful extracellular vesicles (EVs) and enveloped viruses
from biological fluids, utilizing its proprietary lectin-based mechanism. These extracellular vesicles have been implicated in disease
processes such as immune suppression and metastasis in cancer as well as in the progression of severe life-threatening infectious diseases.
The U.S. Food and Drug Administration (“FDA”) has designated the Hemopurifier as a “Breakthrough Device” for two
independent indications:

    ·
    the treatment of individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard of care therapy, and with cancer types in which extracellular vesicles have been shown to participate in the development or severity of the disease; and

    ·
    the treatment of life-threatening viruses for which no approved therapies currently exist.

We are also evaluating the
Hemopurifier’s potential in additional clinical contexts based on its mechanism of action and preclinical findings.

Three clinical sites in Australia—Royal Adelaide
Hospital in Adelaide, Pindara Private Hospital in the Gold Coast, and GenesisCare North Shore Hospital in Sydney—are currently open
for enrollment in our phase 1 oncology trial. As of August 11, 2025, we have treated three participants in the first of three planned
treatment cohorts. The Data Safety Monitoring Board (DSMB), comprising independent medical experts in nephrology and oncology, has reviewed
the data from the initial cohort. Each of the three participants received a single 4-hour Hemopurifier treatment. Based on their evaluation,
the DSMB found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile.
To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported.

Enrollment for Cohort 2 is now open. In this phase,
participants will receive two Hemopurifier treatments over a one-week period at the study's three active clinical sites in Australia.
This trial, which aims to enroll approximately 9 to 18 patients, is designed to evaluate the safety and feasibility of administering the
Hemopurifier at varying dosing intervals in patients with solid tumors who have stable or progressive disease, while receiving treatment
that includes