FDA Grants Aethlon Compassionate Use Approval for its Hemopurifier to Help Fight Ebola

The U.S. Food and Drug Administration (FDA) has granted San Diego, Calif.-based Aethlon Medical Inc. compassionate use approval to use its Hemopurifier therapy as a treatment for the Ebola virus.

Aethlon’s Hemopurifier is a bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals. At present, no antiviral therapy or vaccine has proven to be effective against Ebola virus infection in humans. According to the World Health Organization, nearly 5,000 deaths have been attributed to the current Ebola virus epidemic.  

Based on guidance from FDA, the treatment of Ebola virus infection provides for a unique circumstance where a physician or healthcare provider may wish to pursue the compassionate use of Hemopurifier therapy based on the serious nature of the disease and absence of alternative therapies, according to the company. Compassionate use provisions are typically approved by FDA on an individual patient basis, but may be expanded to include a small group.

Aethlon also disclosed that it plans to submit its first Ebola treatment data to the FDA as a means to support the goal of further expanding treatment access through emergency use regulatory pathways. 

On October 14, the company announced that Hemopurifier therapy had been administered to an Ebola-infected patient at Frankfurt University Hospital in Germany.  The treatment was permitted through special approval from The Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte, BfArM), an independent federal higher authority within the portfolio of the Federal Ministry of Health of Germany. 

“The administration of Hemopurifier therapy in Germany has reinforced the need to clarify defined regulatory pathways that might allow us to treat Ebola infection in the United States,” stated Aethlon founder and CEO, Jim Joyce.  “As it relates to the patient treated in Germany, we respect patient confidentiality and will report on his response to therapy after Frankfurt University Hospital officials provide an update on his condition.”

In the care of Ebola-infected individuals, the Hemopurifier targets two unmet medical needs: the rapid elimination of circulating viruses to inhibit continued progeny virus replication and the direct targeting of shed glycoproteins that overwhelm the host immune response.  The device can be deployed for use within the global infrastructure of dialysis and continuous renal replacement therapy machines already located in hospitals and clinics.

Aethlon is also preparing to initiate U.S. clinical studies of Hemopurifier therapy based on the FDA’s approval of an investigational device exemption that was previously submitted by the company.  The study will contribute safety data to advance the device as a broad-spectrum countermeasure against pandemic threats, including Ebola and chronic viral pathogens such as HIV and Hepatitis C (HCV).

To date, Hemopurifier therapy has been successfully administered in approximately 100 treatment experiences in health-compromised HIV and HCV infected individuals. These studies were conducted at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity Institute, all located in India. In-vitro validation studies that demonstrated the ability of the Hemopurifier to capture Zaire and other strains of Ebola virus were conducted by researchers at the United States Army Medical Research Institute for Infectious Diseases and the U.S. Centers for Disease Control and Prevention.