Aethlon, DaVita to Partner on Device Trials

Aethlon Medical is partnering with DaVita Clinical Research in clinical trials of a device to eliminate germs that can compromise the immune systems of cancer patients.

The Aethlon Hemopurifier is a first-in-class device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that can suppress a cancer patient’s immune system.  It is designed to enhance the effectiveness of interferon-based standard of care or emerging all-antiviral drug regimens, without upping drug toxicity, San Diego devicemaker said.

The FDA approved an investigational device exemption for the Hemopurifier in June 2013.  The resulting feasibility study will test whether the device is safe in treating end-stage renal disease patients who are also infected with Hepatitis C.

Aethlon’s initial plan was to perform the trial at a single clinical site. The partnership with DaVita Clinical Research will allow the company to expand to multiple clinical sites, CEO Jim Joyce said. “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,” he said.

DaVita Clinical Research is an arm of DaVita HealthCare Partners, which operates 2,074 U.S. outpatient dialysis centers serving about 168,000 patients.

Aethlon and DaVita are still finalizing the agreement, including a work order.  The early feasibility trial is expected to begin in the next several months. — Elizabeth Orr

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.