Aethlon Medical Announces Health Canada Approval of Ebola Treatment Protocol
SAN DIEGO, May 13, 2015 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, today disclosed that the Medical Devices Bureau of Health Canada has approved a clinical study protocol to treat Ebola-infected individuals with the Aethlon Hemopurifier®. The Hemopurifier is a first-in-class affinity biofiltration device designed for the broad-spectrum elimination of viral pathogens from the circulatory system of infected individuals. The device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other life-threatening viruses that are not addressed with proven drug therapies. Health Canada is the Federal department responsible for overseeing the health of Canadian citizens.
The Health Canada approved protocol is entitled, "The Treatment of Ebola Virus Disease (EVD) in Humans with the Aethlon Hemopurifier Lectin Affinity Plasmapheresis Device". The protocol allows for an investigational study of Hemopurifier therapy to be conducted in up to 3 human subjects. The objective of the study is to standardize and evaluate the use of the Hemopurifier as supportive care in the treatment of EVD. There is no assurance that the investigational study will result in the collection of clinical data that would support Health Canada licensing requirements. Aethlon further disclosed that the Ebola study protocol had also been approved by the University Health Network (UHN) Research Ethics Board, based in Toronto, Ontario.
Previously, Aethlon disclosed that the United States (U.S.) Food and Drug Administration (FDA) approved a clinical protocol to treat Ebola-infected individuals with Hemopurifier therapy in the U.S. The Company has also submitted a Humanitarian Use Device (HUD) application with FDA to support potential market clearance of the Hemopurifier as a treatment for EVD.
The first administration of Hemopurifier therapy to an ebola-infected individual occurred at Frankfurt University Hospital in Germany. On November 14, 2014, the resulting Hemopurifier treatment data was presented at the American Society of Nephrology (ASN) Annual Meeting by Helmut Geiger, M.D., Chief of Nephrology at Goethe University, Frankfurt University Hospital. Dr. Geiger reported that 242 million Ebola viruses were captured within the Hemopurifier during treatment, a number verified by a post-treatment elution protocol. The elution protocol has since be repeated, which resulted in second measurement of 253 million copies of Ebola virus captured within the Hemopurifier.
Dr. Geiger also reported that the patient's viral load prior to the administration of a single 6.5-hour Hemopurifier treatment was measured at 400,000 virus copies per milliliter of blood (copies/ml). A post-treatment viral load measurement was reported to be 1,000 copies/ml. The treatment was well tolerated with no adverse events reported. At the time of treatment, the Ebola patient was comatose and suffering from multiple organ failure, which required mechanical ventilation, continuous dialysis and the administration of vasopressor medications. The patient made a full recovery and returned home to his family. A publication in the journal "Blood Purification" entitled, "Extracorporeal Virus Elimination for the Treatment of Severe Ebola Virus Disease – First Experience with Lectin Affinity Plasmapheresis." can be accessed online at: http://www.karger.com/Article/Abstract/375229
About Aethlon Medical, Inc.
Aethlon Medical creates affinity biofiltration devices to treat life-threatening diseases. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a first-in-class device that targets the rapid elimination of infectious viruses and cancer promoting exosomes from the circulatory system of treated individuals. Our majority owned subsidiary Exosome Sciences, Inc., is advancing exosome-based liquid biopsies to diagnose and monitor Cancer and Chronic Traumatic Encephalopathy (CTE), a neurodegenerative disorder often found in individuals with a history of repetitive brain trauma.
About The Aethlon Hemopurifier®
Of the hundreds of viruses known to be infectious to man, antiviral drug therapies are approved for fewer than ten. The Aethlon Hemopurifier® provides a broad-spectrum therapeutic strategy to address drug resistant viral pathogens. To date, Hemopurifier therapy has been administered to individuals infected with Ebola virus (Ebola), Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). Time Magazine recently named the Hemopurifier to their list of 'Top 25 Inventions" and "The 11 Most Remarkable Advances in Healthcare." Beyond human treatment experiences, pre-clinical Hemopurifier studies have validated the capture of some of world's deadliest pathogens. These include: Dengue hemorrhagic fever, Lassa hemorrhagic fever, H5N1 avian influenza, H1N1 swine flu virus, the reconstructed 1918 influenza virus, West Nile virus and Vaccinia and Monkeypox, which serve as models for human smallpox infection. U.S. clinical progression of Hemopurifier therapy is being advanced under FDA approved clinical studies.
Aethlon is also investigating the use of Hemopurifier therapy to capture tumor-derived exosomes, a significant unaddressed therapeutic target in cancer care. Tumor-derived exosomes promote cancer progression through multiple mechanisms, which include seeding the spread of metastasis and direct suppression of the immune response. In regards to our therapeutic mechanism of action, the Hemopurifier incorporates a patented affinity technique that allows for selective binding to a unique structure that resides on the surface of tumor-derived exosomes and glycoproteins that coat infectious viruses. Additional information can be found online at www.AethlonMedical.com or you can connect with us on on Twitter, LinkedIn, Facebook and Google+.
Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the ESI will not be able to commercialize its future products, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy or as a broad spectrum defense against viral pathogens, including Ebola, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in the DARPA contract, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Aethlon Medical Contact:
James A. Joyce
Chairman and CEO
(Office) 858.459.7800 x301
Chief Financial Officer
MDM Worldwide Solutions
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SOURCE Aethlon Medical, Inc.
Released May 13, 2015