Aethlon Medical, Inc., a pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, announced that the Institutional Review Board (IRB) of the University of California, Irvine (UCI) has approved a multi-indication clinical study entitled, "Plasma Exosome Concentration in Cancer Patients Undergoing Treatment."

Aethlon previously disclosed that it had entered into investigator-initiated clinical trial agreement with UCI, which was pending IRB approval.  Under the approved clinical protocol, the study will seek to enroll five individuals in each of nine defined tumour types for a total study population of up to 45 subjects.  The tumour types include the following forms of cancer; breast adenocarcinoma, colorectal, gastric & gastroesophageal, pancreatic, cholangiocarcinoma, lung (NSCLC), head & neck (SCC), melanoma and Ovarian adenocarcinoma. The principal investigator of the study is Edward Nelson, M.D.

The study endpoints include establishing baseline exosome levels and monitoring changes in circulating exosome concentration associated with tumour treatment and the association of longitudinal changes in circulating exosome concentrations with response to treatment. Recruitment of participants in the study will be through the use of internal and outside referrals to the University of California, Irvine Medical Center (UCIMC).

The clinical study will also provide data to help direct future clinical investigations of the Aethlon Hemopurifier as a therapeutic candidate to reduce the presence of circulating tumour-derived exosomes, which are known to suppress the immune system of cancer patients and contribute to the spread of metastasis. The Hemopurifier is a first-in-class biofiltration device that targets the single-use removal of viruses and tumour-derived exosomes from the circulatory system.

Aethlon Medical creates medical devices that target unmet therapeutic needs in infectious disease and cancer.  The company's lead product is the Aethlon Hemopurifier, a first-in-class device that selectively targets the rapid elimination of circulating viruses and tumour-secreted exosomes that promote cancer progression.