Medical Device Daily
In the latest chapter in its ongoing drive toward commercialization of its Hemopurifier, Aethlon Medical (San Diego) said it has submitted an investigational device exemption to the FDA requesting permission to initiate human safety studies as well as a treatment counter-measure against select category “A” bioterror threats.
Those bioterror threats now include Ebola hemorrhagic virus and Marburg hemorrhagic virus, Aethlon’s CEO/chairman James Joyce told Medical Device Daily.
“The IDE is focused directly on the treatment of Category A bioterror threats, and these are threats that the government feels have the highest likelihood of being weaponized as agents against our civilian and military population,” Joyce said.
Parallel to the safety studies, which the company has said will include 10 human subjects, will be in vitro tests in which human blood infected with these pathogens will be treated using the Hemopurifier to measure its effectiveness.
“From the standpoint of Category A pathogens, there are no efficacy studies that can be performed because from a humanitarian standpoint, you can’t expose humans to those pathogens,” he said.
The Hemopurifier is an extracorporeal device designed to treat people infected with drug and vaccine-resistant pathogens, including HIV. It is meant to mimic the natural immune response of clearing infectious viruses and toxins before the occurrence of cell and organ infection, the company said.
The company is not doing animal studies of its Hemopurifier cartridge. “One of the problems” in doing animal studies is that animal data does not always provide useful information for humans, Joyce said.
Aethlon’s cartridges are “only designed for the single-use removal of pathogens from blood [and] a means of augmenting the immune response to recover from infection of improve the performance of therapeutics when they do exist,” he said.
The Hemopurifier device is meant to mimic the natural immune response of clearing infectious viruses and toxins before the occurrence of cell and organ infection, the company said. It is based on hollow fiber dialysis and affinity chromatography, the company said.
There are no existing therapeutics for such diseases as the Ebola virus. In fact, there are “only a few” facilities in the U.S. that will allow access for and handling of such pathogens. But Joyce said his company was fortunate enough to have relationships with “three of the four Biosafety Level 4 facilities,” facilities that do permit such pathogens within their labs.
The three labs Joyce was referring to are at the Centers for Disease Control and Prevention (CDC; Atlanta), USAMRIID (Fort Detrick, Maryland) and the Southwest Foundation for Biomedical Research (San Antonio).
He said in addition to the Ebola virus, the studies will also involve “other Category A viruses,” which he declined to discuss in detail.
At least since 2001, the company has bannered the Hemopurifier as potentially the first device that could be used to treat HIV infection. Indeed, in August, Joyce was invited to speak at The AIDS Institute’s Treatment Horizons Forum, held in conjunction with the XVI International AIDS Conference in Toronto (Medical Device Daily, Aug. 16, 2006).
At the time, Aethlon reported a human safety study for health-compromised individuals that had been conducted at the Apollo Hospital (Delhi, India) that included 24 Hemopurifier treatments, each lasting four hours without material adverse events.
The company also wants to use its device for treatment of influenza, including the possibly pandemic-producing Avian flu.
In reporting its IDE submission to the FDA, Aethlon also said that Nathan Levin, director of the Renal Research Institute (RRI; New York) has agreed to be principal investigator of the studies. The RRI is a joint venture between Fresenius Medical Care (Bad Homburg, Germany), which focuses on dialysis treatment, and Beth Israel Medical Center (New York). Aethlon said that its study is slated to be conducted at Beth Israel, pending internal review by the hospital.