Feb. 26, 2014
/PRNewswire/ -- Aethlon Medical, Inc. (OTCQX:AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that that it has reached an agreement in principle with DaVita Clinical Research® (DCR) 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.
DCR is a specialty contract research organization (CRO) with experience in conducting more than 300 early phase clinical trials. As a subsidiary of DaVita Healthcare Partners, DCR has access to one third of the total US end-stage renal disease (ESRD) patient population and maintains a network that exceeds 150 investigative physicians practices at more than 250 clinical sites.
Aethlon previously disclosed that the United States Food and Drug Administration (FDA) had approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in
the United States
. Under the feasibility study protocol, Aethlon is to enroll ten ESRD patients infected with Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease indications.
"Not long after the FDA had cleared our IDE, we were presented an opportunity to advance a clinical relationship with DaVita Clinical Research," stated Aethlon Chairman and CEO,
. "As a result, we have transitioned our clinical plan from working with a single-site institute to working with a single institute that has a multitude of clinical sites across
the United States
. Beyond maintaining the resources necessary to advance our feasibility study, DaVita's proven extracorporeal expertise, patient accrual capabilities and expansive clinical infrastructure provide a foundation to support our long-term vision of treating a variety of infectious disease and cancer indications."
Aethlon further disclosed that the DCR agreement was entered into on a non-exclusive basis and is pending the completion of a definitive agreement, which will include a work order describing the full scope of services to be provided by DCR to Aethlon Medical.