Company: AEMD
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001683168-25-008271
Chunk: 59

Company: AETHLON MEDICAL INC
Filing Date: 2025-11-12
Form: 10-Q
Item: Item 8
Chunk 59
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 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 Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®).

The Company previously received formal approval
from India’s Central Drugs Standard Control Organization (CDSCO) to initiate an oncology clinical trial at Medanta Medicity Hospital.
Following subsequent discussions with the Company’s India-based contract research organization (CRO), it was determined that first
patient treatment would likely not occur until early 2026. In light of this extended timeline and after evaluating the associated costs
and strategic priorities, the Company elected not to proceed with the India study. This decision enables the Company to focus its resources
on advancing its ongoing clinical trial in Australia, which remains more closely aligned with its objective of generating timely clinical
data to support a potential Premarket Approval (PMA) 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.

 18 

In addition to our ongoing clinical trials, we
continue to explore potential new applications for the Hemopurifier through internal pre-clinical research. In the quarter ended June
30, 2025 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.
In the study we evaluated the Hemopurifier’s ability to remove disease-relevant extr