Public healthAethlon Medical says its Hemopurifier can serve in counter-bioterror applications

Aethlon Medical's Hemopurifier unit // Source: redchip.com

San Diego-based Aethlon Medical, a developer of therapeutic filtration devices to address infectious disease and cancer, said yesterday that it has reestablished efforts to advance the Aethlon Hemopurifier within U.S. government programs that support the development and purchase of treatment countermeasures against bioterror threats. The company describes the Aethlon Hemopurifier as the first medical device selectively to target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. Based on studies conducted by government and nongovernment research organizations, Aethlon says it believes the Hemopurifier represents the most advanced and perhaps the only true broad-spectrum countermeasure against viral threats most likely to be weaponized against civilian and military populations.

Therapeutics able to target multiple bioterror threats have become a focal point of the U.S. Health and Human Services Department (HHS) and dual-use therapies such as the Hemopurifier, which also have commercial applications against established disease conditions such as hepatitis-C virus (HCV) and cancer, are no longer precluded from consideration to be supported by government programs.

“Revamped government policies expand the opportunity for our Hemopurifier in the United States and improve our potential access to non-dilutive capital resources, which are not capped by the public market value of our organization,” stated Aethlon chairman and CEO, Jim Joyce. “We now plan to update an investigational device exemption (IDE) already submitted to the FDA, which if approved, would allow us to collect further clinical data that potentially could contribute to other infectious disease and cancer studies we hope to initiate in the United States.”

The IDE previously submitted to the FDA by Aethlon specifies the Hemopurifier as a medical device for the single-use removal of bioterror related viruses from circulation. As efficacy studies against such pathogens cannot be conducted in humans, the demonstration of treatment safety represents the primary treatment challenge in humans. While efficacy studies against such threats may not be permissible, Aethlon has demonstrated significant viral load reductions in HIV and HCV infected individuals. The company says that in vitro studies have verified that the Hemopurifier has broad-spectrum capabilities against both bioterror and emerging pandemic threats. These studies confirmed the ability of the Hemopurifier to capture Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.

“The landscape to encourage countermeasure development is rapidly improving,” the company says. Last month, the Obama administration announced it would seek to improve government efforts to spur development of countermeasures for potential biological-weapon agents and HHS declared that programs intended to prepare the country for biological weapons attacks would be overhauled with a focus toward decreasing the length of time it takes to produce new medical countermeasures, and that new institutes would be established to collaborate with small firms on the production of new treatments. Additionally, funding will be directed to the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to turn scientific breakthroughs into medical countermeasures. From a regulatory perspective, the FDA has indicated that it will take steps to eliminate obstacles that could slow the pace of the countermeasure review process.