Healthcare Industry News: Bard
News Release - January 22, 2008
The Aethlon Hemopurifier(R) Proves Effective in Capturing Bird Flu VirusSAN DIEGO--(HSMN NewsFeed)--Aethlon Medical, Inc., (OTCBB:AEMD ) a pioneer in developing therapeutic devices for infectious disease, today disclosed that researchers have demonstrated the effectiveness of the Aethlon Hemopurifier® in capturing the highly-fatal H5N1 strain of the Avian Flu Virus (Bird Flu.) In pre-clinical studies, high concentrations of H5N1 flu virus (~ 3 million flu virus/ml) were observed to be rapidly depleted from cell culture fluids when circulated through the Hemopurifier®. The study data indicated that during a six-hour testing period, the Hemopurifier® removed up to 99.4 percent of infectious H5N1 flu virus. Verification of viral capture was documented by both real-time PCR and conventional plaque assay (TCID 50) measurements.
“The data provides real hope for a post-infection treatment against pandemic influenza and further reinforces the ability of our Hemopurifier® to address a broad spectrum of viral conditions,” stated James A. Joyce, Chairman and CEO of Aethlon Medical. “Additionally, it appears possible that the use of the Hemopurifier® could open the door for drugs previously considered incapable of providing clinical benefit as a stand-alone therapy.”
The Aethlon Hemopurifier® is a medical device designed for the single use removal of infectious viral pathogens from blood. The device, which augments the natural immune response of clearing infectious viruses and toxins before cell and organ infection, is positioned to fill a void in treating drug and vaccine resistant infectious diseases. In order to further support the use of the Hemopurifier® as a broad-spectrum treatment countermeasure against bioterror and pandemic threats in the United States, Aethlon will include this new data in a forthcoming submission to the U.S. Department of Health and Human Services (HHS) and the newly established Biomedical Advanced Research and Development Authority (BardA.) Based on the significance of the H5N1 data and the continued demonstration of safety in human studies, Aethlon may on a limited basis provide the Hemopurifier® to countries that request the Hemopurifier® as a treatment option for infected citizens. Researchers at the Battelle Biomedical Research Center conducted the H5N1 studies.
It is feared that the H5N1 strain of avian influenza virus, whose mortality rate in infected humans exceeds 60 percent, will spark a global epidemic should it evolve to allow for an efficient spread of host-to-host infections in humans. The recent discovery that H5N1 avian influenza virus can spread via the bloodstream to organs and other regions of the body typically not attacked by influenza viruses explains in part, the high virulence of H5N1 infection and why it remains a serious pandemic threat. The ability of H5N1 virus to proliferate in blood represents a causative effect for triggering hypercytokinemia (cytokine storm), a direct parallel to the Spanish Flu of 1918, which reportedly killed up to 40 million people within 20 months. Though governments and health agencies are stockpiling antiviral drugs to treat influenza, these therapies have yet to demonstrate effectiveness against human H5N1 infection. A further complication to drug treatment has arisen from the clinical observation that drug absorption appears impaired in severely ill H5N1 patients, and in H5N1 patients with gastrointestinal symptoms.
Researchers believe the removal of circulating H5N1 hemagglutinin, a surface protein that is deleterious to the host and immune system, combined with the removal of infectious H5N1 virus would be clinically beneficial to infected patients. Corresponding to this belief, the Hemopurifier® targets the rapid removal of both infectious H5N1 virus and immunosuppressive H5N1 hamagglutinin from circulation. As a result, Aethlon believes the Hemopurifier® is positioned to benefit infected patients, both as a stand-alone therapeutic, and as an adjunct treatment able to improve the clinical benefit of other candidate therapies.
About Battelle Biomedical Research Center
Battelle Biomedical Research Center is a research group in the National Security Global Division of Battelle Memorial Institute, an organization that provides solutions to some of the world's most important challenges through its three global businesses: National Security, Energy Science and Technology, and Health and Life Sciences. Battelle is the world's largest independent research and development organization with technology contributions that find their way into hundreds of commercial products each year. Conducting multi-billion dollars in global R&D annually, Battelle oversees over 20,000 employees in more than 120 locations worldwide, including five national laboratories that Battelle manages or co-manages for the U.S. Department of Energy. Battelle was recently approved by the Department of Health and Human Services (HHS) under the Select Agent Programs of the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) to carry out studies on highly pathogenic avian influenza, including the H5N1 strain. Battelle was established in 1929 as a non-profit charitable trust and is headquartered in Columbus, Ohio. For more information, visit www.battelle.org.
About Aethlon Medical
Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device to treat infectious disease. The Hemopurifier® addresses the largest opportunity in infectious disease, the treatment of drug and vaccine resistant viruses. The Hemopurifier® is a single use extracorporeal device that converges hollow-fiber filtration technology with immobilized affinity agents to capture viruses and soluble glycoproteins from the blood. The device has been designed to mimic the natural immune response of clearing infectious viruses and immunosuppressive proteins from circulation. Regulatory and commercialization initiatives in the United States are focused on bioterror threats, while international initiatives are directed toward naturally evolving pandemic threats, and chronic infectious disease conditions including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Collaborative studies to demonstrate utility of the Hemopurifier® are being conducted with researchers at the Government of India’s National Institute of Virology (NIV), The Centers for Disease Control and Prevention (CDC), The United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and The Southwest Foundation for Biomedical Research (SFBR). Aethlon recently demonstrated safety of the Hemopurifier® in a 24-treatment human study and is now conducting follow-on safety studies at the Fortis Hospital in Delhi, India. The Company has also submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) related to advancing the Hemopurifier® as a broad-spectrum treatment countermeasure against category “A” bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier® technology can be accessed online at www.aethlonmedical.com.
Certain of the 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, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company’s ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company’s proprietary technology, 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.
Source: Aethlon Medical
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