We’re Developing Medical Countermeasures with Broad-Spectrum Capabilities
Statement regarding Aethlon’s position with respect to the potential for use of the Hemopurifier as a countermeasure against the current coronavirus SARS-CoV-2 (COVID-19) outbreak
The Hemopurifier is an investigational device that has not yet received FDA approval for any indication. Aethlon continues to investigate the potential for the use of the Hemopurifier in viral diseases under an open Investigational Device Exemption (IDE) and our FDA Breakthrough Designation for “…the treatment of life-threatening glycosylated viruses that are not addressed with an approved therapy.” The Company currently has an open FDA approved Expanded Access Protocol for the treatment of Ebola infected patients in the U.S. and a corresponding HealthCanada approval in Canada.
Based on our studies to date, the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV and Ebola. We do have data suggesting that it could clear a closely related coronavirus (MERS).
We do not yet have access to materials from SARS-CoV-2 (the causative agent in COVID-19) for testing, but we are working on obtaining access to some of these materials.
We also do not know whether clearing SARS-CoV-2 from the blood, which is what the Hemopurifier is designed to do, would have a positive effect on this disease, which primarily targets the lung.
Even if effective, the Hemopurifier would only potentially be indicated in those patients with the most severe and life-threatening manifestations.
We will continue to disclose material progress in our investigation of the potential for the Hemopurifier in this and other indications.
Supporting an initiative set by the U.S. Department of Health and Human Services
Emerging pathogens pose a significant threat to mankind. Of the hundreds of viral pathogens known to be infectious to man, only a few are addressed with proven antiviral drug or vaccine therapies. Beyond the looming threat of bioterrorism, a proliferation of international travel, urban crowding and global warming is expected to accelerate the emergence of future pandemics. In response, the U.S. Department of Health and Human Services (HHS) has established an initiative to support platform technology medical countermeasures with broad-spectrum capabilities. Based on preclinical studies and human treatment experiences, the Aethlon Hemopurifier® defines this initiative.
Administered to individuals infected with Ebola, Hepatitis C and HIV
To date, Hemopurifier therapy has been administered to individuals infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In the case of Ebola, a remarkable response to a single administration of Hemopurifier therapy (comatose physician with multiple organ failure at the time), led to Time Magazine naming the Hemopurifier to be one of the "Top 25 Inventions" as well as one of the "Eleven Most Remarkable Advances in Healthcare."
Status of clinical studies
Beyond human treatment experiences, pre-clinical Hemopurifier studies have validated the broad-spectrum capture of numerous viral threats. These include: Chikungunya, Dengue and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection. Specific to pandemic influenza threats, Aethlon has validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which represents a model for the strain of influenza that killed an estimated 50 million victims in 1918 and 1919. In vitro studies of other viral threats are ongoing.