Aethlon Medical (OTC:AEMD) plans to begin U.S. clinical trials for its Hemopurifier device by the end of the year for the treatment of hepatitis C and hopes to eventually expand testing to cover such deadly pathogens as Ebola, Aethlon CEO Jim Joyce told MassDevice.com.
Aethlon scored a victory last week when doctors in Germany announced that an Ebola patient who had undergone treatment with the device was now virus-free and on the road to recovery.
The device was used in combination with other therapies to treat the patient, who at 1 point experienced multiple organ failure, according to a press release.
The Hemopurifier is a blood-filtering cartridge containing "affinity" agents that attract and "trap" specific viruses and immunosuppressive proteins. Aethlon says the device works by hindering the virus’s ability to replicate while allowing the immune system to rebound.
The company sees the device, which can be easily hooked up to a dialysis or CRRT machine, being used in combination with other therapies, such as antiviral drugs. Because Ebola is known to replicate with great speed in the body, Aethlon has long considered the Hemopurifier as a plausible treatment for the devastating disease, Joyce told us.
Even before the current outbreak, which has claimed nearly 5,000 lives worldwide, government researchers were conducting laboratory tests to see if the device could effectively remove the Ebola virus from blood.
"We’ve demonstrated with the [Centers for Disease Control & Prevention] that the device was successful in capturing 4 strains of Ebola, including Zaire," Joyce said. It’s the "Zaire" Ebola strain that’s wreaking havoc in West Africa.
The Hemopurifier has already been shown to be effective in reducing viral loads in 100 dialysis patients infected with either hepatitis C or HIV. Setting up a regulatory approval pathway for deadly diseases like Ebola, however, has been tricky.
"The challenge is that you can’t conduct efficacy studies for humanitarian reasons," Joyce said. "You can only do safety studies."
Joyce said that the company plans to initiate a safety study by the end of the year, if not sooner, testing the product on patients with HCV. The study would be conducted under a previously granted investigational device exemption for infectious diseases.
"We can bridge off that study for other pathogens," he explained. The company also hopes to be able to use data collected from the Ebola patient in Germany.
With an IDE study in place, U.S. doctors would then be able to use Hemopurifier to treat Ebola under the FDA’s "compassionate use" provision. In the case of a major outbreak, the product could be used under an emergency use authorization, but only if a medical emergency was declared by the U.S. Health & Human Services Dept., Joyce said.
Aethlon also plans to file an IDE for testing the Hemopurifier as a treatment for certain cancers. The company hopes to submit its application during 1st first quarter of 2015.
