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The Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class therapeutic device designed for the treatment of life-threatening viral infections which cannot be addressed with an approved treatment. On September 12, 2017, Aethlon received an FDA Expedited Access Pathway (EAP) Designation for its Hemopurifier® device, a single-use cartridge that can capture a broad spectrum of highly glycosylated viruses including influenza and hemorrhagic fevers, such as Ebola virus, to reduce viral load in the circulatory system.
The FDA established the EAP program to facilitate rapid patient access to breakthrough technologies which has a potential to address life-threatening disease conditions for which no approved or cleared treatment alternatives exist.
Aethlon, working in collaboration with leading government and non-government research institutes, has validated the ability of the Hemopurifier® to capture a broad-spectrum of pandemic influenza viruses, mosquito-borne viruses, and deadly hemorrhagic viruses. Based on its use to treat Ebola virus, the Hemopurifier® was named a “Top 25 Invention” and one of the “Eleven Most Remarkable Advances in Healthcare,” by TIME Magazine in 2014.
The Aethlon/iBio Collaboration
Aethlon/iBio stated that they have collaborated in order to advance large-scale production of a proprietary recombinant form of Galanthus Nivalis Agglutinin (GNA). The GNA produced with iBio’s plant-based technology can be immobilized within the Hemopurifier® to bind infectious enveloped viruses. Researchers from the two companies has earlier conducted a feasibility study to produce and screen a panel of recombinantly produced lectin isoforms, which can improve binding capacity and reduce the reliance on less effective extracted mixtures.
Jim Joyce, Chairman and CEO of Aethlon, stated:
“The production of recombinant GNA in iBio’s large-scale manufacturing facilities establishes a pathway for us to access a consistent, high quality supply that can support our long-term clinical and commercialization objectives.”
Sponsored by Department of Defense
iBio’s CDMO facilities were initially designed and constructed under sponsorship of the Defense Advanced Research Projects Agency (DARPA) of the US Department of Defense. These facilities have the capacity to initiate a rapid production response to an infectious disease outbreak or a bioterror attack and to manufacture large quantities of recombinant proteins under Current Good Manufacturing Practices (cGMP’) of the US Food and Drug Administration.
About iBio, Inc.
iBio provides a range of product and process development, analytical, and manufacturing services at the large-scale development and manufacturing facility of its subsidiary iBio CDMO, LLC., located in Bryan, Texas. The facility houses laboratory and pilot-scale operations as well as large-scale automated hydroponic systems capable of growing over four million plants as “in process inventory” and delivering over 300 kilograms of therapeutic protein pharmaceutical active ingredient per year.
Last Close Stock Review
On Tuesday, October 17, 2017, the stock closed the trading session at $0.32, advancing 2.79% from its previous closing price of $0.31. A total volume of 628.47 thousand shares have exchanged hands. iBio’s stock currently has a market cap of $30.01 million.