Aethlon Medical, Inc. Announces Early Feasibility Study of the Hemopurifier
September 29, 2022 at 09:05 pm
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Aethlon Medical, Inc. 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.
Aethlon Medical, Inc. (Aethlon) is a medical therapeutic company focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections suppression, seed the spread of metastasis and inhibit the benefit of cancer therapies. The Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression. Hemopurifier helps to bind and clear multiple different glycosylated viruses, such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), Dengue, West Nile, multiple strains of influenza, Ebola, Chikungunya, smallpox, monkeypox, multiple herpes viruses, a MERS-CoV related pseudovirus, and others. Hemopurifier is used as a device for two independent indications: the treatment of individuals with advanced or metastatic cancer and the treatment of life threating viruses that are not approved therapies.