Aethlon Medical Secures FDA Clearance For Amendment In Initial-Stage COVID-19 Study

The U.S. Food and Drug Administration (FDA) has approved an amendment to the protocol of the ongoing clinical trial investigating Aethlon Medical’s AEMD lead therapy Aethlon Hemopurifier for patients with severe COVID-19.

The agency has approved protocol amendment to eliminate the inclusion criteria that patients must have a dialysis catheter in place and have tolerated dialysis at the time of screening.

Charles J. Fisher, Jr., Chief Executive Officer, said, “We anticipate that this protocol amendment will enable us to enroll patients at an increased rate now that dialysis treatment is no longer a study requirement. We look forward to providing access to this potentially life-saving therapy to patients in need.”

Aethlon Hemopurifier is a therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. The Phase 1 study is designed to evaluate Hemopurifier for upto 40 enrolled subjects with severe COVID-19.

Price action : Aethlon Medical shares are trading around 3 percent down at $1.00 on Monday at the time of publication.