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Aethlon Hemopurifier Effective in Capturing West Nile Virus
Business Wire, May 6, 2008
SAN DIEGO -- Aethlon Medical, Inc. (OTCBB:AEMD) today announced that pre-clinical studies have documented that the Aethlon Hemopurifier[R] is effective in capturing circulating West Nile Virus (WNV). The study data further supports the potential use of the Hemopurifier[R] as a broad-spectrum treatment against viral pathogens, whether naturally occurring, or purposely released as biological weapons of mass destruction. During in vitro studies, high concentrations of WNV (approximately 700 thousand WNV/ml) were depleted from cell culture fluids when circulated through the Hemopurifier[R]. The study data indicated that the Hemopurifier[R] removed 53 percent of infectious WNV in the first four hours of the testing; 79 percent at six hours; and 99.3 percent after 20 hours. The studies were conducted in triplicate, and data verification was provided by real-time polymerase chain reaction (PCR).
"The WNV study reinforces the stature of our Hemopurifier[R] as a leading broad-spectrum treatment candidate for viral pathogens, and further demonstrates the potential to fill the void in treating yet another infectious disease condition not addressed by vaccines or antiviral drug therapies," stated James A. Joyce, chairman and CEO of Aethlon Medical.
West Nile Virus is considered a Category "B" bioterror and pandemic threat by the National Institute of Allergy and Infectious Diseases (NIAID). It was first documented in the Western hemisphere in 1999, believed to have entered via an infected bird or mosquito, the common vectors. Incidence of infection in the U.S. has since increased with approximately 3,600 cases reported in 2007, 33 percent of which were classified as a neuroinvasive disease, the most severe form of WNV, and resulted in 121 fatalities. Health officials believe that there is significant underreporting of WNV infection. At present there is no vaccine to protect against WNV, nor is there any specific treatment procedure to manage the disease upon infection.
Data from Aethlon's WNV study will be included in a June 4th response to a government contract opportunity entitled "Application of Platform Technologies for the Development of Therapeutic Agents for Biodefense". The contract solicitation (DMID-NIAID-NIHAI20080022BARDA) represents a partnership between NIAID and the recently established Biomedical Advanced Research and Development Authority (BARDA) to award contracts that fund the development and evaluation of innovative approaches to treat NIAID category A, B and C bioterror threats. Contract recipients will be awarded up to five years of funding directed toward activities including, research, clinical programs, and the establishment of large-scale manufacturing protocols. A significant emphasis of the contract solicitation is to aid in the development of broad-spectrum therapies able to demonstrate effectiveness against multiple bioterror pathogens and toxins. To reinforce the broad-spectrum capabilities of the Hemopurifier[R], Aethlon's contract response will also include supporting pre-clinical data against; Dengue hemorrhagic fever, Ebola hemorrhagic fever, Lassa hemorrhagic fever, H5N1 avian influenza (Bird Flu), the reconstructed 1918 influenza virus, Human immunodeficiency virus (HIV), Hepatitis-C virus (HCV), and vaccinia and monkeypox, which both represent models associated with human smallpox infection.
Virtually all of the pathogens considered to be material bioterror threats are untreatable with traditional drug and vaccine therapies. Effective treatments are either non-existent, of limited usefulness, or vulnerable to both naturally emerging and intentionally engineered pathogens. Innovative therapies offering broad-spectrum activity against different classes of microbes could potentially be effective against both traditional and non-traditional threats. Broad-spectrum therapies also provide the possibility that a limited number of treatment countermeasures could replace the need for the staggering number of pathogen-specific drugs that would be required for emergency use in bioterror and pandemic threat programs. Additionally, broad-spectrum strategies that are able to overcome drug resistance could extend the clinical utility of existing therapies. For these reasons, the U.S. Department of Health and Human Services (HHS) recently mandated that therapies able to demonstrate broad-spectrum effectiveness against multiple pathogens are to be the focal point of government programs that fund the development and commercialization of countermeasures against bioterror and pandemic threats. Aethlon Medical considers the Hemopurifier[R] to be the leading broad-spectrum candidate as evidenced by its breadth of pre-clinical data and human treatment experience.
About Aethlon Medical
Aethlon Medical is the developer of the Hemopurifier[R], a first-in-class medical device designed to treat infectious disease. The Hemopurifier[R] provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and is positioned to address the treatment of drug and vaccine resistant viruses. Additionally, the device holds promise in cancer care, as research studies have verified the Hemopurifier[R] is able to capture immunosuppressive particles secreted by tumors. The Hemopurifier[R] is designed to act both as a stand-alone therapeutic, and as an adjunct treatment to enhance clinical benefit of established therapies. Pre-clinical studies conducted by researchers representing leading government and non-government health organizations both in the United States and abroad have documented the effectiveness of the Hemopurifier[R] in capturing from circulation the viruses that constitute pandemic threats, including H5N1 Avian Influenza (bird flu), and Dengue Hemorrhagic Fever (DHF). The company is conducting studies to support the use of the Hemopurifier[R] as a broad-spectrum treatment countermeasure against bioterror threats, including Smallpox, and Ebola, Marburg, and Lassa hemorrhagic fever. Regulatory and commercialization initiatives in the United States are presently focused on bioterror threats, while international initiatives are directed toward naturally evolving pandemic threats, and chronic infectious disease conditions including the Human Immunodeficiency Virus (HIV) and Hepatitis-C (HCV). Aethlon demonstrated the safety of the Hemopurifier[R] in a 24-treatment human study at the Apollo Hospital in Delhi, India, and is currently conducting further human studies at the Fortis Hospital, also located in Delhi. The company has submitted an investigational device exemption (IDE) to the U.S. Food and Drug Administration (FDA) to advance the Hemopurifier([R])as a broad-spectrum treatment countermeasure against category "A" bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier([R]) technology is available online at www.aethlonmedical.com.
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