Aethlon Medical Announces First Patient Completes Hemopurifier® Clinical Study Protocol
SAN DIEGO, Feb. 26, 2015 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, today announced that the first patient enrolled in the Company's FDA approved feasibility study has completed their full Hemopurifier® treatment protocol without any device-related adverse events. The study protocol, which is being administered at DaVita Med Center Dialysis in Houston, is enrolling ten chronic dialysis patients infected with Hepatitis C virus (HCV) to receive a six treatment protocol of Hemopurifier therapy. The Aethlon Hemopurifier is a first-in-class bio-filtration device that provides the broad-spectrum elimination of infectious viruses from the circulatory system of infected individuals.
The feasibility study will contribute safety data to advance the Hemopurifier as a candidate therapy to address chronic conditions such as HIV and HCV, as well as acute bioterror and pandemic threats that are not addressed with proven drug or vaccine therapies. A detailed description of the study, including treatment protocol and patient inclusion/exclusion criteria can be accessed online at www.clinicaltrials.gov
"With our feasibility study now under way, we will initiate our previously communicated plan to file Humanitarian Use Device (HUD) submissions that provide a potential FDA market clearance pathway to treat viral indications that affect fewer than 4,000 individuals in the U.S. each year," stated Jim Joyce, Chairman and CEO of Aethlon Medical.
To date, Hemopurifier therapy has been administered outside the United States in the treatment of Ebola, HIV and HCV-infected individuals. Previously, in vitro studies of bioterror and pandemic threats have verified Hemopurifier capture of Ebola hemorrhagic virus, dengue hemorrhagic virus, lassa hemorrhagic virus, H5N1 avian influenza (bird flu), the reconstructed 1918 influenza virus (r1918), 2009 H1N1 influenza virus (swine flu), West Nile virus, and monkeypox, which serves as a model for human smallpox infection. These studies were conducted with leading government and non-government research organizations, including The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), The Centers for Disease Control and Prevention (CDC), The National Institute of Virology (NIV), The Battelle Biomedical Research Center (BBRC) and The Southwest Foundation for Biomedical Research (SFBR).
About Aethlon Medical, Inc.
Aethlon Medical creates medical devices that target unmet therapeutic needs in 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. Additional information can be found online at 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.
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 February 26, 2015