To submit its first ebola treatment data to the FDA soon
Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease and cancer will provide Hemopurifier® therapy under FDA compassionate use access provisions to support potential requests by qualified physicians and institutes that may seek to treat ebola virus infection in the United States.
The Aethlon Hemopurifier® is a first-in-class 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 (WHO), 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 health care provider may wish to pursue the compassionate use of Hemopurifier® therapy based on the serious nature of the disease and absence of alternative therapies. 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 14th, 2014, 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. 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,”stated Aethlon founder and CEO, Jim Joyce.
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 CRRT 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 (IDE) 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).
EP News Bureau–Mumbai
