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Aethlon Medical Responds to U.S. Government Initiative to Develop and Acquire Broad-Spectrum Biodefense Countermeasures
Business Wire, March 28, 2007
SAN DIEGO -- Aethlon Medical, Inc. (OTCBB:AEMD), announced today that the U.S. Government has disclosed plans to support research, development, acquisition, storage/maintenance, deployment, and utilization of broad-spectrum treatment countermeasures able to address multiple bioterror and pandemic threats. The preeminent focus of prior government initiatives has been fixed defenses attempting to align a specific treatment with each known bioterror and pandemic threat. Aethlon Medical believes its Hemopurifier([R]) treatment technology is a leading broad-spectrum countermeasure candidate. The Hemopurifier([R]) is designed to assist in the treatment of multiple bioterror threats, including Smallpox, Ebola, Marburg, Lassa fever, and potentially genetically engineered viruses purposely developed to defeat traditional drug and vaccine therapy.
The shift toward broad-spectrum countermeasures is documented within the new Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise Strategy (HHS PHEMCE Strategy), which outlines goals and objectives that HHS will employ to ensure that medical countermeasures are available for high priority bioterror threats. The changes implemented under the HHS PHEMCE Strategy have been posted in the Federal Register dated March 20, 2007.
"The HHS directive clears a path for us to advance the development and commercialization of our Hemopurifier([R]) through mainstream government programs," stated Aethlon Chairman and CEO James A. Joyce. "The directive also validates our long-stated belief that broad-spectrum countermeasures should be a focal point for protecting our civilian and military populations from emerging bioterror and pandemic threats," concluded Mr. Joyce.
As stated within the HHS PHEMCE Strategy, HHS will pursue development and acquisition of medical countermeasures that address multiple threats. The plan supports the development of flexible defenses to allow for innovations in medical countermeasure design that may result in enhanced products. For example, the benefit of broad-spectrum pharmaceuticals and platform technologies will extend beyond their ability to counter current biological threat agents and will allow for rapid response to future threats. As such, HHS has established a long-term strategy to support the development of novel, broad-spectrum medical countermeasures.
Under the HHS PHEMCE strategy, The National Institutes of Health (NIH) will continue its existing research and development efforts to identify medical countermeasures for known as well as emerging diseases. HHS will utilize the newly established Biomedical Advanced Research and Development Authority (BARDA) in the Pandemic and All-Hazards Preparedness Act to provide direct investment in medical countermeasure advanced research and development. Finally, HHS will use the Project BioShield special reserve fund and the Strategic National Stockpile resources to acquire, store, maintain, and deploy top priority medical countermeasures.
The PHEMCE is a coordinated, intra-agency effort led by the Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes three HHS internal agencies: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). The HHS PHEMCE strategy can be accessed online at: www.hhs.gov/aspr
About Aethlon Medical
Aethlon Medical has developed a first-in-class medical device to assist in the treatment of infectious disease. The device, known as the Hemopurifier([R]), is a platform technology positioned to be a broad-spectrum treatment for drug- and vaccine-resistant bioweapons, naturally evolving pandemic threats, and chronic infectious disease targets including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). On March 6, 2007, Aethlon submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) requesting permission to initiate human safety studies of the Aethlon Hemopurifier([R])as a treatment countermeasure against select category "A" bioterror threats. Additional studies to demonstrate utility of the Hemopurifier([R])as a countermeasure against bioterror threats are being conducted with researchers at 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). Category "A" bioterror threats are defined by the CDC as agents that pose a risk to national security; are easily disseminated or transmitted from person to person; result in high mortality rates; may cause public panic and social disruption; and require special action for public health preparedness. Global researcher Frost & Sullivan awarded the Hemopurifier([R]) the 2006 Technology Innovation Award, and The AIDS Institute presented Aethlon with the 2007 Innovative HIV Life Sciences Leadership Award. The Company has also initiated research on a second-generation Hemopurifier([R]) that targets the capture of growth factors inherent in the spread of Cancer. More information on Aethlon Medical and the Hemopurifier(TM) technology can be found at www.aethlonmedical.com.
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