Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 9

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 9
---
, Haryana 12200, India.
The patient tolerated one HP treatment daily for three days. On 19 February 2022, in the first 15 min during the 3rd treatment, one nonserious
Grade 2 AE was reported (hemolysis and leaking of the filter). The filter was replaced, and therapy resumed without sequalae. On Day #4
the patient suffered asystole and died due to clinical deterioration unrelated to the device. During the first Hemopurifier treatment
(T1) there was a gradual decrease in viral load from the baseline at 4923 copies/mL decreasing steadily to 1307 copies/mL over five hours,
indicating a 73% reduction from baseline. At the beginning of the second Hemopurifier treatment (T2), the viral load was 850 copies/mL,
dropped below the lower limit of quantification within an hour, and remained undetectable, suggesting rapid clearance. The viral load
before the third treatment (T3) was below the quantification limit but unexpectedly rose at 3 hours (636 copies/mL), peaking at 4 hours
(1583 copies/mL), and slightly decreasing at 5 hours (1104 copies/mL). This irregular pattern suggests possible delayed RNA release, sample
variability, or another biological factor affecting detection. The cumulative data shows a reduced SARs-CoV-2 viral load during the first
two Hemopurifier treatments but not during the third treatment.

Due to lack of eligible patients
in the ICU the clinical trial was closed as November 22, 2022.

Oncology- U.S. Clinical Trial in Head and Neck
Cancer

A single center clinical trial
entitled “Depleting Exosomes to Improve Response to Immune Therapy in Head and Neck Squamous Cell Cancer: An Early Feasibility Phase
I Clinical Trial” was conducted under a US IDE at the University of Pittsburgh. This was a single arm Phase 1 clinical trial designed
to evaluate the safety and efficacy of the Hemopurifier plus pembrolizumab for the treatment of patients with recurrent or metastatic
head and neck squamous cell cancer. All patients were treated with pembrolizumab every 21 days as standard of care. The patients were
to receive a 4-hour Hemopurifier treatment before Pembrolizumab infusions 2 occasions 21 days apart. A total of 2 patients were enrolled
in the study with the first occurring on