Aethlon Medical Discloses Expanded Access "Emergency Use" Pathway To Treat Ebola in the United States
SAN DIEGO, Nov. 19, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease and cancer, disclosed today that it will provide Hemopurifier® therapy under FDA expanded access "emergency use" provisions to support requests from qualified physicians and institutes that may seek to treat ebola virus infection in the United States.
Aethlon previously disclosed that it would provide Hemopurifier® therapy on a humanitarian basis through FDA compassionate use access provisions, which allow for the use of an investigational device to treat an individual patient or small group based on clearance by FDA prior to treatment.
Based on FDA guidance, Aethlon will now provide Hemopurifier® therapy to treat Ebola infection through expanded access "emergency use" provisions in the United States. Expanded access "emergency use" of an investigational device does not require advance FDA approval for life threatening circumstances for which an alternative therapy is not available. At present, no antiviral therapy or vaccine has proven to be effective against Ebola virus infection in humans.
The Aethlon Hemopurifier® is a first-in-class bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals. In the treatment of Ebola, Aethlon recently announced that Hemopurifier® therapy was administered to Ugandan physician, who was infected with Ebola in Sierra Leone where he was treating Ebola patients. At the time of treatment, which occurred at Frankfurt University Hospital in Germany, the patient was unconscious and suffering from multiple organ failure.
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). Post-treatment viral load was measured at 1,000 copies/ml and never again rose above that level. The treatment was well tolerated with no adverse events reported. Additionally, a post-treatment elution protocol verified that 242 million Ebola viruses were captured within the Hemopurifier® during treatment. Since the administration of Hemopurifier® therapy, Frankfurt University Hospital officials have reported that the Ebola virus is no longer detectable in the patient's blood and full recovery is expected.
Aethlon will soon begin the first U.S. clinical Hemopurifier® studies following the United States Food and Drug Administration's (FDA)'s approval of an Investigational Device Exemption (IDE). The study will contribute safety data to advance the device as a broad-spectrum countermeasure against pandemic threats, including Ebola and chronic viral pathogens such as HIV and Hepatitis C (HCV).
About Aethlon Medical, Inc.
Aethlon Medical creates targeted therapeutic devices to address infectious disease, cancer and neurodegenerative disorders. The company's lead product is the Aethlon Hemopurifier®, a first-in-class device that selectively targets the rapid elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression. Exosome Sciences, Inc. is a majority owned subsidiary that is advancing exosome-based products to diagnose and monitor cancer, infectious disease and neurological disorders. For more information, please visit http://www.aethlonmedical.com/ and connect with the Company 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.
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SOURCE Aethlon Medical, Inc.
Released November 19, 2014