Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 1568

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 9C
Chunk 1568
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 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 either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes or exosomal particles have been shown to participate in the development or severity of the disease; and

    ·
    the treatment of life-threatening viruses that are not addressed with approved therapies.

Oncology

We believe that the Hemopurifier
may be a substantial advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove
harmful remove harmful extracellular vesicles particles that promote the growth and spread of tumors. In October 2022, we formed a wholly-owned
subsidiary in Australia to initially conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier
in Australia.

We completed an in vitro
binding study of extracellular vesicles from cancer patient samples, to provide pre-clinical evidence to support our trial design and
translational endpoints. Our study indicated positive results from this study, providing evidence that our Hemopurifier removes extracellular
vesicles, or EVs, from plasma. This translational study provides pre-clinical evidence to support our phase 1 safety, feasibility and
dose-finding clinical trials of our Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1
monotherapy treatment, such as Keytruda® or Opdivo®.

We have launched in an Australia
safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or progressive
disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The primary endpoint
of the approximately nine to 18-patient, is safety. Exploratory analyses will be conducted to explore the number of HP treatments required
to produce sustained reductions of EVs as well as improve anti-tumor T cell activity. We plan to open a similarly designed trial in India.

The following three hospitals
in Australia have received ethics committee approval, have gone through training on our device and are open for patient enrollment: Royal
Adelaide Hospital