Company: AEMD
Filing Date: 2025-02-12
Form Type: 10-Q
Source: 0001683168-25-000960
Chunk: 78

Company: AETHLON MEDICAL INC
Filing Date: 2025-02-12
Form: 10-Q
Item: Item 2
Chunk 78
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 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, safety, feasibility and dose-finding trial in each country is safety.

In addition to monitoring safety, the study is
designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles (“EVs”)
and whether these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central
laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by
regulatory agencies.

The following two hospitals in Australia have received
ethics committee approval, have gone through training on our device and are now open for patient enrollment: Royal Adelaide Hospital in
Adelaide, Australia and Pindara Private Hospital in the Gold Coast section of Australia. We have also trained a third hospital, GenesisCare
North Shore in Sydney, Australia, and have received ethics committee and research governance approval for that institution. The site will
be activated and open for enrollment pending completion of the site investigation meeting scheduled for February 2025. In late January
2025, Royal Adelaide Hospital successfully administered the Hemopurifier treatment to the first patient, with no adverse events.

 20 

We have received ethics committee approval from
Medanta Medicity Hospital in Gurugram, India for a similar nine to 18-patient, safety, feasibility and dose-finding trial. We are completing
the necessary logistical steps before they can open for patient enrollment.

We have entered into an agreement with North American
Science Associates, LLC (“NAMSA”), a world leading medical technology contract research organization (“CRO”) offering
global end-to-end development services, to oversee our clinical trials of the Hemopurifier for patients in Australia with various types
of cancer tumors. We also have engaged Qualtran LLC as the CRO for our clinical trial in India.

We also believe that the Hemopurifier can be part
of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an
already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals
infected