Company: AEMD
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001683168-25-006049
Chunk: 7

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-13
Form: 10-Q
Item: Item 1
Chunk 7
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 Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®).

The Company previously pursued approval of a similar
clinical trial in India. We received formal approval from the Indian regulatory agency, the Central Drugs Standard Control Organization
(CDSCO), to conduct this trial in India on July 7, 2025. We were working with our India CRO, Qualtran, toward site initiation at Medanta
Medicity Hospital. However, after reviewing extended timelines associated with site activation and trial execution, we made the decision
to cancel the Indian trial to conserve resources and to concentrate efforts on the Australian oncology trial.

The
Hemopurifier is designed to address life-threatening viral infections, particularly those involving highly glycosylated viruses for which
there are no approved therapies. It has previously been used under FDA and international regulatory frameworks to treat individuals infected
with HIV, hepatitis C, Ebola, and SARS-CoV-2. While our COVID-19 clinical trials in the U.S. and India have been terminated due to low
ICU enrollment, these programs provided real-world evidence of Hemopurifier use in critically ill patients. We maintain an open IDE for
viral indications, preserving the ability to respond to future outbreaks or emerging pathogens.

     8 

In addition to our ongoing clinical trials, we continue to explore potential
new applications for the Hemopurifier through internal pre-clinical research. In the first fiscal quarter of 2026, results of our pre-clinical
ex-vivo study entitled “Ex Vivo Removal of CD41 positive platelet microparticles from Plasma by a Medical Device containing a Galanthus
nivalis agglutinin (GNA) affinity resin” were published in the pre-print vehicle bioRxiv. This manuscript has been submitted to
a peer-reviewed publication for review. In the study we evaluated the Hemopurifier’s ability to remove disease-relevant extracellular
vesicles (EVs), including those derived from platelets, which are implicated in cancer, autoimmune disease, and neurological disorders.
The study demonstrated >98% removal of platelet-derived EVs from healthy human plasma in a simulated clinical session. We are also
collaborating with academic researchers to investigate EV characteristics in patients with Long COVID. These exploratory programs are
intended to inform potential future clinical indications and expand the utility of the Hemopurifier platform. 

Successful outcomes of human
trials will also