By M. Marin
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Growing Database Supporting Hemopurifier’s Positive Treatment of COVID-19
Last week Aethlon Medical (NASDAQ:AEMD) announced that the Aethlon Hemopurifier® produced positive results in treating two patients who were critically ill with COVID-19.1 Neither patient was expected to survive. The Hemopurifier therefore was used under the FDA emergency use authorization (EUA). In other words, the use of a treatment that has not yet been fully approved by the FDA was implemented because the doctors were out of options.
Case #1: Improvement in COVID-related coagulopathy, lung injury, and inflammation & tissue injury
After about three weeks, doctors requested Hemopurifier treatment for the patient in Case #1 under EUA. The patient received daily Hemopurifier treatment and, importantly, tolerated the procedure well, with no evidence of allergic reaction, thrombotic complications or hemolysis.
Following Hemopurifier treatment, the patient in Case #1 was observed without demonstrable COVID-19 viremia. The presence of viremia – or the active virus circulating in the blood – has been associated with disease severity and the development of multi-organ failure.
Treatments also showed improvement in COVID-19-associated coagulopathy (CAC), lung injury, inflammation, and tissue injury. AEMD believes that the improvements reflect the Hemopurifier’s removal of exosomes with noxious microRNA cargo and that the removal of exosomes contributed to the patient’s recovery.
There were observed decreases in total exosomal concentration in the patient compared to prior to the Hemopurifier treatment and the patient’s acute lung injury improved. The patient received eight Hemopurifier treatments without complications and eventually was weaned from a ventilator and discharged from the hospital.
The findings suggest that benefits from the Hemopurifier in COVID-19 may extend beyond viral removal and might also reflect the elimination of exosomes. Just as the Hemopurifier is being evaluated for the ability to remove exosomes to treat cancer patients, treatment in Case #1 demonstrates that exosomes are also involved in the cell-to-cell spread of COVID-19 infection and its associated inflammation, coagulopathy and complement activation.
Case #2: First ever demonstrated in vivo removal of SARS-CoV-2 virus from infected patient’s blood
The second patient was a 67-year-old man with a history of coronary artery disease and newly diagnosed diabetes, among other disorders, who also had acute kidney injury. The case is notable for the first-ever demonstration of in vivo removal of SARS-CoV-2 virus from the blood stream of an infected patient. The patient completed a six hour Hemopurifier treatment without complications and was placed on Continuous Renal Replacement Therapy (CRRT). Although the patient ultimately died after CRRT because his disease was at an advanced stage, the Hemopurifier treatment showed that it could be beneficial.
In summary, the two case studies indicate that the Hemopurifier successfully cleared SARS-CoV-2 virus and associated exosomes from the blood stream. AEMD demonstrated the removal of COVID-19 from a viremic patient by the Hemopurier for the first time ever. Moreover, total exosome concentrations and noxious exosomal microRNAs associated with coagulopathy and acute lung injury also decreased with Hemopurier treatments.
➢ Successfully cleared SARS-CoV-2 virus from the blood stream of an infected patient.
➢ Successfully cleared associated exosomes from the blood stream of an infected patient.
➢ Patients tolerated Hemopurier treatment without side effects
➢ Lowered noxious exosomal microRNAs associated with coagulopathy and acute lung injury
We believe the company continues to build its database of positive outcomes using the Hemopurifier.
In addition to the outcomes noted above, AEMD is currently conducting an Early Feasibility Study (EFS) of patients with COVID-19, as well as another clinical study in patients with head and neck cancer. The growing database from these EUA patient cases and the clinical studies is expected to contribute to potential FDA regulatory approval. Moreover, the several beneficial outcomes noted with the two EUA patients also point to the potential versatility of the Hemopurfier, which could, in turn, also imply a growing commercial opportunity for AEMD.
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1. Removal of COVID-19 Spike Protein, Whole Virus, Exosomes and Exosomal microRNAs by the Hemopurifier® Lectin-Affinity Cartridge in Critically Ill Patients with COVID-19 Infection