Previously, the device was used under the FDA’s emergency-use authorization in patients infected with Hepatitis C, HIV and the Ebola virus.
Aethlon’s Hemopurifier device is a single-use, disposable cartridge designed to target and filter out viruses or tumor-secreted exosomes. Blood flows through the cartridge into nearly 3,000 hollow fibers with pores 250 nanometers in diameter. A pressure deferential in the 1st third of the fiber pushes particles below 250 nanometers through the pores into a space between the fibers and the cartridge.
There an affinity agent binds to a disease-specific structure associated with viruses. The structure is something viruses co-opt from the host’s own cells during replication to avoid detection from the host’s immune system. But within the device, that signature is what binds viruses to the cartridge. Everything else continues to flow through the device.
The feasibility study demonstrated that the Hemopurifier was well tolerated with patients with end-stage renal disease who were also infected with Hepatitis C. There were also no device-related adverse events, according to Aethlon.
“We achieved our primary study objective, which was to demonstrate that our Hemopurifier can be safely administered to very health-compromised individuals,” chairman & CEO Jim Joyce said in prepared remarks. “We will now proceed to submit a final report and look forward to collaborating with our FDA review team to establish market clearance pathways to treat viral threats that are not well addressed with traditional drug therapies.”
Although the study was originally slated to enroll 10 participants, the company closed enrollment after treating 8 patients since the Hemopurifier was well-tolerated.
In November, Joyce spoke with MassDevice and told us the story of how the company’s Hemopurifier device helped to save the life of a Ugandan physician who was working on the front-lines of the Ebola epidemic.
After almost 7 hours of treatment with the single cartridge blood filtration device, the patient’s viral load dropped from 400,000 virus copies per milliliter of blood to 1,000 copies per milliliter. The doctor eventually made a full recovery.