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Aethlon Medical Announces First Patient Treated in First-in-Human Clinical Trial of HEMOPURIFIER® in Head and Neck Cancer
Study is evaluating the HEMOPURIFIER® for reducing cancer-associated exosomes prior to the administration of standard-of-care KEYTRUDA® The HEMOPURIFIER® is
About this update from Aethlon Medical, Inc.
[{"type":"text","content":"Study is evaluating the HEMOPURIFIER® for reducing cancer-associated exosomes prior to the administration of standard-of-care KEYTRUDA®\n The HEMOPURIFIER® is an FDA designated \"Breakthrough Device\" for depleting circulating exosomes\n\n\nSAN DIEGO, Dec. 16, 2020 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the first patient has been treated in the Company's first-in-human Early Feasibility Study (EFS) evaluating the HEMOPURIFIER® in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA. (Hemopurifier Plus Pembrolizumab in Head and Neck Cancer - Full Text View - ClinicalTrials.gov). \nThe EFS, which is the device equivalent of a Phase 1 clinical trial for a drug or biologic, is a single center, open label trial in 10 to 12 subjects. The study is evaluating the HEMOPURIFIER® for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA®), which is a first-line therapy for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The primary endpoint for the study is safety of the HEMOPURIFIER® in a clinical setting. Secondary endpoints include efficacy based on response rates, progression-free and overall survival, and changes in exosome concentration after HEMOPURIFIER® treatment. \nIn cancer, exosomes have been shown to participate in the development and advancement of disease. Exosomes derived from tumor cells may promote immune suppression and seed the spread of metastasis. These tumor derived exosomes may also inhibit the activity of immuno-oncology drugs such as KEYTRUDA®. Tumor derived exosomes are not currently addressed with any approved therapy.\nDan Zandberg, M.D., Medical Oncologist and Hematologist at UPMC Hillman Cancer Center, Associate Professor of Medicine at the University of Pittsburgh School of Medicine and Principal Investigator of the study, stated, \"We are excited to have treated the first head and neck cancer patient with the HEMOPURIFIER®. While KEYTRUDA® can markedly improve outcome in some head and neck cancer patients, the majority of patients still do not resp...