AethlonMedical logoAethlon Medical, Inc. (Nasdaq: AEMD) is developing a medical device that is an extra-corporeal blood filtration system. A key indication is the removal of infectious disease virus particles from the blood stream. The FDA has granted Aethlon an Expedited Access Pathway (EAP) to test its device on a broad range of infectious disease targets. 

In a recent press release Aethlon stated: “Aethlon proposed the following "indication for use" in its EAP submission; The Hemopurifier is a single-use device indicated for the treatment of life-threatening highly glycosylated viruses that are not addressed with an approved treatment." To date, the Hemopurifier has been validated to capture a broad-spectrum of viruses that are highly glycosylated, including life-threatening strains of pandemic influenza viruses, mosquito-borne viruses as well as hemorrhagic viruses that are not addressed with an approved treatment”.

The device is designed to be effective in binding highly glycosylated viruses. This is a broad-range mandate from FDA to test the device in many infectious disease situations including influenza, Dengue, Chickungunya, Zika, Hep C and many others that are highly glycosylated. The device is based on the ability of a lectin protein, Galanthus nivalis agglutinin (GNA), to bind highly-glycosylated coat proteins of infectious viruses and remove them from the bloodstream with a modified plasmapheresis hollow fiber device. Lectin affinity plasmapheresis (LAP) has seen limited clinical use in the Ebola epidemic in Africa and reported in the literature (12). The authors reported that the device was successful in removing Ebola virus particles and envelope glycoproteins that produce significant cytokine response. The report concluded that all other therapies including traditional vaccines, mAb therapy and potential RNA vaccine therapy will all benefit from LAP and that more studies are warranted. Hepatitis C virus removal has also been documented using LAP. A recent study reported an average of 29% removal of viral load in a single treatment when combined with their dialysis treatment. Viral load reduction can improve the outcome of peg-interferon / ribavirin treatment. Physical reduction of viral load will benefit treatments for a number of viral infections (13). 

With the recent FDA approval for opportunistic application of the technology for a broad base of viral infection the application of this technology can be evaluated on a broad number of applications in infectious disease. This will allow access by global NGO’s and the Defense department as a potential platform to lower mortality in both natural infectious diseases and deliberate biothreats. The iBio team has produced a unique GNA, GNA 109. Natural Galanthus lectins are a group of isoforms. The initial request from Aethlon was to produce GNA 105. Our team cloned a series of Galanthus lectins and developed a binding assay that will be cGMP compliant. GNA-109 was far superior in binding than the GNA-105 and other isoforms. One of the problems for Aethlon was the supply of Galanthus lectin. The world supply is small and the quality is variable. Therefore, to build a compliant device with natural source supply was difficult and performance was hard to reproduce. 

With a rGNA-109 from iBio the supply is stable and reproducible and can be made under cGMP compliance to satisfy the FDA requirements for combination devices. The potential for improved binding capacity with GNA-109 has been demonstrated by Aethlon and can now be applied to the clinical application. iBio has signed a memorandum of understanding with Aethlon to become its exclusive manufacturing partner. 
 
iBio is also being considered by Aethlon to manufacture the entire hemopurifier device. iBio has a dedicated classified suite for formulation and a second suite for filling.