Aethlon Medical, Inc. (OTCBB:AEMD) disclosed that it has initiated studies to test the in vitro effectiveness of the Aethlon Hemopurifier® to capture a partially reconstructed version of the Spanish Flu of 1918, a viral pandemic outbreak that killed approximately 40-50 million people during a 25-month time span. The reconstructed 1918 influenza used in the Hemopurifier® studies is a recombinant virus that has two genes (the HA and NA) from the 1918 strain of influenza along with six genes from the Texas 91 influenza strain. The resulting research virus is known as 1918 HA/NA:TX/36/91.
The 1918 HA/NA:TX/36/91 studies are designed to evaluate the potential of the Hemopurifier® to treat future outbreaks of pandemic influenza, and to further demonstrate the broad-spectrum effectiveness of the Hemopurifier® to capture viral pathogens. The studies will be conducted at a global contract research organization that previously collaborated with Aethlon Medical on pre-clinical testing of the Hemopurifier® against the highly fatal H5N1 Avian Flu Virus (bird flu). In those studies, the Hemopurifier® proved effective in removing up to 99.4 percent of infectious H5N1 from cell culture fluids during a six-hour testing period.
The U.S. Department of Health and Human Services (HHS) has recently mandated that therapies able to demonstrate broad-spectrum effectiveness against multiple pathogens, including pandemic influenza, be the focal point of government programs that support the commercialization of candidate countermeasures against bioterror and pandemic threats. Aethlon Medical considers the Hemopurifier® to be the leading broad-spectrum candidate as evidenced by its breadth of pre-clinical data and human treatment experience. Data resulting from the 1918 HA/NA:TX/36/91 study and other clinical programs will be included in a forthcoming submission to HHS and the recently established Biomedical Research and Development Authority (BARDA) to advance the commercialization of the Hemopurifier® as a broad-spectrum countermeasure against bioterror and pandemic threats.
About the Spanish Flu of 1918
The Spanish Flu of 1918 lasted from March 1918 to June 1920 (25 months) and is estimated to have killed 40-50 million people worldwide. As a comparison, approximately 25 million AIDS related deaths have occurred during the first 25 years of the disease. In contrast to most influenza outbreaks, the primary victims of the Spanish Flu of 1918 were healthy young adults. Researchers believe the virulence associated with the 1918 virus was triggered by an overreaction of the immune system, known as a cytokine storm. As a result, juveniles and elderly with weaker immune systems had a lower incidence of morbidity and mortality. The fatality rate of those infected with the Spanish Flu of 1918 is estimated at 2.5-5 percent. Scientists have reported the 1918 Spanish flu virus was initially a bird flu virus that evolved to be efficiently passed in human-to-human transmissions. Alarmingly, the greater than 50 percent human fatality rate of today's H5N1 bird flu virus is also associated with the cytokine storm. Justifiably, researchers believe further studies of the reconstructed 1918 influenza virus may provide scientific insight necessary to advance therapeutic strategies able to address future pandemic influenza outbreaks.
About Aethlon Medical
Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device designed to treat infectious disease. The Hemopurifier® provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and is positioned to address the treatment of drug and vaccine resistant viruses. The device also holds promise in cancer care, as research studies have verified the Hemopurifier® able to capture immunosuppressive particles that are secreted by tumors. The Hemopurifier® is targeted for use a stand-alone therapeutic, and as an adjunct treatment to enhance clinical benefit of established and candidate 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® in capturing pandemic threats, including H5N1 Avian Influenza (bird flu), and Dengue Hemorrhagic Fever (DHF) from circulation. Studies are also being conducted to support the use of the Hemopurifier® 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 has previously demonstrated safety of the Hemopurifier® 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) 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 is available online at aethlonmedical.
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.
Aethlon Medical
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