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Item 8.01 Other Events.
Aethlon Medical, Inc. (the “Company”) previously announced the U.S. Food and Drug Administration’s approval on October 4, 2019 of its Investigational Device Exemption application to initiate an Early Feasibility Study (“EFS”) of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda). The primary endpoint for the EFS, which is designed to enroll 10 to 12 subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. This study, which is being conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, (“UPMC”) has treated two patients to date. Due to lack of further patient enrollment, the Company and UPMC are in the process of terminating this study at UPMC. At this time, the Company is considering adding one or more alternative sites to this trial to accelerate recruitment and is in the process of designing other clinical trials in oncology.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AETHLON MEDICAL, INC.
|Date: September 29, 2022||By:||/s/ James B. Frakes|
James B. Frakes
Chief Financial Officer
ATTACHMENTS / EXHIBITS
XBRL SCHEMA FILE
XBRL LABEL FILE
XBRL PRESENTATION FILE