Aethlon Medical, Inc. has announced that the U.S. FDA has approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in the country. The Hemopurifier targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation.
According to the World Health Organization (WHO), Hepatitis C virus (HCV) is a blood-borne pathogen that affects upwards of 170 million people, or rather more meaningfully, 2-3% of the world’s population. It is a leading cause of cirrhosis and liver transplantation.
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The company’s Aethlon ADAPT™ System is a technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier®, which specifically selects HCV, among other diseases. The system is uniquely positioned as an adjuvant to be incorporated with either interferon-based standard of care (SOC) or emerging all-antiviral drug regimens without adding drug toxicity
Under the feasibility study protocol, Aethlon will enroll ten end stage renal disease (ESRD) patients who are infected with the 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 conditions.
“Obtaining FDA’s permission to initiate human studies has been our most important objective for several years,” stated Jim Joyce, Chairman and CEO of Aethlon Medical. “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.”
Source: Aethlon Medical, Inc.