Aethlon Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an amendment to the protocol of its ongoing clinical trial investigating the Aethlon Hemopurifier(R) for patients with severe COVID-19. The newly approved protocol amendment eliminates the inclusion criteria that patients must have a dialysis catheter in place and have tolerated dialysis at the time of screening. The Aethlon Hemopurifier is a therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood.

Aethlon is currently evaluating the safety and feasibility of the Hemopurifier in an active Early Feasibility Study (EFS), analogous to a Phase 1 clinical trial for a drug or biologic, which is designed to enroll up to 40 severe COVID-19 patients [NCT04595903]. Aethlon recently announced that the first patient has completed Hemopurifier treatment in the trial and that there are nine hospitals actively screening patients. Aethlon is working with PPD, Inc., an established contract research organization (CRO), to advance this clinical study.

Aethlon and the Hemopurifier(R)Aethlon Medical is a medical technology company developing the Hemopurifier, a therapeutic blood filtration system indicated for infectious diseases and cancer. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and harmful exosomes from blood utilizing a proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases.

The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. Under an Investigational Device Exemption (IDE) application, the FDA approved a single site, open-label Early Feasibility Study (EFS) to evaluate the Hemopurifier for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA(R)) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The EFS is being conducted at the University of Pittsburgh Medical Center Hillman Cancer Center.

The Hemopurifier also holds an FDA Breakthrough Device designation and an open IDE application related to the treatment of life-threatening viruses that are not addressed with approved therapies. A recent amendment to the IDE enabled Aethlon to implement a new EFS protocol to treat up to 40 COVID-19 patients at up to 20 clinical sites in the U.S. In two case studies of patients treated under Emergency Use (EU), the Hemopurifier demonstrated binding of SARS-CoV-2 spike protein and removal of SARS-CoV-2 virus from the circulation of a human patient.