Aethlon Medical moves forward with Hemopurifier

Published 8 December 2006

System removes viral pathogens such as Marburg and smallpox from human circulation; company requests an investigational device exemption under Project BioShield; dengue-related tests to begin in India

San Diego, California-based Aethlon Medical has asked the Food and Drug Administration to approve an investigational device exemption (IDE) for its Hemopurifier device designed to remove viral pathogens such as smallpox, ebola, and Marburg from human circulation. The company recently completed a 24-treatment human safety study at the Apollo Hospital in Delhi, India, where the Hemopurifier’s safety was tested on dialysis patient suffering from Hepatitus-C infection. The demonstration of treatment safety is a primary endpoint in human studies because human efficacy studies of bioweapon threats are not ethically permissible.

The device is being developed under Project BioShield, the $5.6 billion initiative best known for its failure to develop a new anthrax vaccine. In addition to funding, BioShield also provides incentives such as regulatory fast track and priority review provisions, opportunities for early commercialization under Emergency Use Authorization (EUA) programs, and stockpile purchase orders prior to regulatory approval. A critical element of the process, an IDE allows for a device to be used in a clinical study and is a major step towards receiving pre-market approval.

In related news, Aethlon also announced that it has agreed to collaborate with researchers at the India-based National Institute of Virology to test the Hemopurifier as a potential treatment for dengue fever.

-read more in this company news release