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Aethlon Medical Announces U.S. FDA Approval of Hemopurifier COVID-19 Study Protocol Amendment
Approval eliminates the requirement for previous dialysis treatment, potentially enabling accelerated enrollment in the ongoing clinical study SAN DIEGO, July
About this update from Aethlon Medical, Inc.
[{"type":"text","content":"Approval eliminates the requirement for previous dialysis treatment, potentially enabling accelerated enrollment in the ongoing clinical study\nSAN DIEGO, July 11, 2022 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an amendment to the protocol of its ongoing clinical trial investigating the Aethlon Hemopurifier® for patients with severe COVID-19. The newly approved protocol amendment eliminates the inclusion criteria that patients must have a dialysis catheter in place and have tolerated dialysis at the time of screening.\n\"We are pleased that the FDA has approved our protocol amendment for the COVID-19 trial,\" said Charles J. Fisher, Jr., M.D., Chief Executive Officer of Aethlon Medical. \"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.\"\nThe Aethlon Hemopurifier is a therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. Aethlon is currently evaluating the safety and feasibility of the Hemopurifier in an active Early Feasibility Study (EFS), analogous to a Phase 1 clinical trial for a drug or biologic, which is designed to enroll up to 40 severe COVID-19 patients [NCT04595903]. Aethlon recently announced that the first patient has completed Hemopurifier treatment in the trial and that there are nine hospitals actively screening patients.\n\"We have learned from our study sites during screening, from data presentations and from thought leaders in the field that the incidence of COVID-19-induced kidney injury, resulting in the need for kidney replacement therapy (KRT), has decreased dramatically during the course of the pandemic,\" said Steven LaRosa, M.D., Chief Medical Officer of Aethlon Medical. \"As such, we worked closely with the FDA to construct updated wording in the protocol and informed consent that allows patients to participate in the study who do not already require KRT yet still protects patient safety.\"\n\"This protocol amendmen...