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| Aethlon Medical's Hemopurifier device--Courtesy of Aethlon Medical |
As med tech companies home in on innovative ways to quell the growing Ebola outbreak, Aethlon Medical ($AEMD) snagged FDA approval for a clinical trial of its biofiltration device in patients with the virus.
The San Diego, CA-based company's Hemopurifier product filters viruses and toxins from the blood of individuals infected with Ebola, targeting antiviral drug resistance and serving as a first-line defense against the virus, the company said in a statement. Aethlon plans to launch an investigational study of the device at up to 10 U.S. clinical sites and enroll as many as 20 U.S. subjects in the trial. Therapy with the Hemopurifier will be administered to patients for 6 to 8 hours daily until their Ebola viral load drops below 1,000 copies/ml of blood.
Aethlon has already chalked up some promising results for its biofiltration therapy for Ebola, touting data presented in November at the American Society of Nephrology Annual Meeting that showed 242 million Ebola viruses were captured with the Hemopurifier during the treatment of a critically ill patient. The treatment also reduced the patient's Ebola viral load from 400,000 virus copies/ml of blood to 1,000 copies/ml of blood with no reported adverse events, the company said in a statement.
But the FDA's approval of a clinical study of the device does not come without a catch; in order to test its Hemopurifier in individuals with Ebola, Aethlon will have to distinguish results from a co-current trial of the product, which is being tested in individuals with hepatitis C who receive chronic dialysis. The company must report any adverse events from the new Ebola trial to the FDA within 10 working days of the device's use, Aethlon said in a statement.
Meanwhile, med tech outfits and researchers are hard at work developing potential therapies for the deadly virus. Scientists at Harvard University are creating a device that acts like a human spleen and filters deadly pathogens out of the blood, treating 90 ailments including Ebola and HIV. In November 2014, the Bill & Melinda Gates Foundation said it would back new trials of treatments and plasma-based therapy for Ebola, funneling $5.7 million into the effort.
"We are committed to working with Ebola-affected countries to rapidly identify and scale up potential lifesaving treatments for Ebola," Dr. Papa Salif Sow, a senior program officer and infectious diseases expert with the foundation's Global Health Program, said in an earlier statement. "The Gates Foundation is focusing its R&D investments on treatments, diagnostics and vaccines that we believe could be quickly produced delivered to those who need them if they demonstrate efficacy in stopping the disease."
- read Aethlon Medical's statement