Jan 2 (Reuters) - Aethlon Medical Inc said the U.S. Food and Drug Administration had approved the testing in Ebola patients of its bio-filtration device, which was used against the deadly virus in a critically ill patient in Germany who later recovered.
The device, being developed as a broad-spectrum countermeasure against pandemic threats, filters viruses and toxins from the blood.
It is currently being tested in India for its ability to accelerate viral load depletion when used in combination with hepatitis C standard-of-care drug therapy.
Patients will be treated for six to eight hours daily with the device, called Aethlon’s Hemopurifier, until the Ebola viral load drops below 1,000 copies/ml.
Aethlon said on Friday that the FDA’s approval allows for an Ebola study to be conducted in up to 20 infected subjects in the United States.
Treatment with the company’s device in the acutely-ill patient at Frankfurt University Hospital in Germany reduced the patient’s viral load to 1,000 copies/ml from 400,000 following a 6.5 hours of therapy, Aethlon said.
San Diego-based Aethlon’s shares closed at about 26 cents in the over-the-counter market on Wednesday.
The largest Ebola outbreak on record has killed at least 7,905 people so far. (Reporting by Natalie Grover in Bengaluru; Editing by Sriraj Kalluvila and Ted Kerr)