TUESDAY, JUNE 19, 2018

Aethlon announces FDA approval of IDE to treat HCV patients

Aethlon Medical, Inc., a San Diego-based medical device company, announced on Tuesday that the U.S. Food and Drug Administration approved an investigational device exemption to enable human feasibility tests of the Aethlon Hemopurifier.

The Hemopurifier is a device that targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation. Aethlon will enroll 10 end-stage renal disease patients infected with the hepatitis C virus to demonstrate the safety of therapy with the Hemopurifier.

If the feasibility study is successful, it will allow for Aethlon to conduct important studies needed for market clearance to treat HCV and other conditions.

"Obtaining FDA's permission to initiate human studies has been our most important objective for several years," Jim Joyce, the chairman and CEO of Aethlon Medical, said. "I salute the perseverance of our dedicated Aethlon team, their families, and loyal shareholders whose support allowed us to endure the challenges of navigating through FDA. We plan to reward your faith with clinical execution and progression toward a marketable therapy in the United States."

The Hemopurifier can be used as an adjuvant with existing HCV treatment methods without adding drug toxicity. The device selectively binds to unique high mannose signatures abundant on the outer membrane of infectious viral pathogens and on the surface of cancer-secreted glyocoproteins and exosomes.

HCV is a blood-borne pathogen that affects more than 170 million individuals and is a leading cause of liver transplantation and cirrhosis.

"Aethlon Medical has been laying the groundwork necessary to implement the now approved clinical trial protocol for several years," Rod Kenley, Aethlon's president, said. "We are finally able to move forward with our contract research and clinical partners in finalizing all of the activities that can now take place prior to initiating treatment of the first patient. While there is still some work to be done, today the biggest hurdle has been cleared and we are anxious to make rapid progress towards commercialization."