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February 26, 2014
08:15 EDTAEMD, DVAAethlon Medical signs agreement with DaVita for clinical management services
Aethlon Medical (AEMD) has reached an agreement in principle with DaVita (DVA) subsidiary DaVita Clinical Research to provide clinical management services that will support forthcoming studies of the Aethlon Hemopurifier. The Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that suppress the immune system of cancer patients.
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September 2, 2014
09:31 EDTAEMDAethlon Medical receives IRB approval to initiate hemopurifier studies
Aethlon Medical has received independent internal review board approval to initiate human clinical studies of Hemopurifier therapy at DaVita MedCenter Dialysis located in Houston, Texas. Aethlon previously disclosed that the United States Food and Drug Administration had approved an Investigational Device Exemption that would allow for the initiation of Hemopurifier feasibility studies in the United States. As a result of the independent IRB approval, the company is now permitted to initiate the IDE approved study. Enrollment of patients who meet the study inclusion/exclusion criteria is expected to begin in the coming weeks. The Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that suppress the immune system of cancer patients. Under the feasibility study protocol, Aethlon will enroll ten end-stage renal disease patients who are infected with the Hepatitis C virus to demonstrate the safety of Hemopurifier therapy in an infectious disease model. Upon successful completion of the feasibility study, Aethlon plans to conduct pivotal efficacy studies required for market clearance to treat HCV and other chronic viral indications. Previous clinical studies of Hemopurifier therapy have been conducted in HIV and HCV-infected individuals at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity Institute, all located in India.

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