Aethlon Medical To Submit Project BioShield Related Regulatory Plan.SAN DIEGO -- Aethlon Medical, Inc., (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AEMD AEMD Automotive Electric Motor Drive (US Department of Energy program) ) announced today that its first regulatory submission in the United States will focus on bioterror threats addressed under Project BioShield. In this regard, Aethlon plans to submit a formal Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) to the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in the first quarter of 2007. The Company has already submitted a preliminary IDE and recently met with FDA officials to present a clinical plan to initiate human studies of its Hemopurifier(TM), a device designed to remove infectious viral pathogens from circulation. Under Project BioShield, the Hemopurifier(TM) is positioned as a broad-spectrum countermeasure against bioterror threats, including Smallpox, Ebola, and Marburg virus. Project BioShield, a $5.6 billion initiative signed into law on July 21, 2004, provides incentives that encourage organizations to develop treatment countermeasures against category "A" biological weapons. Such incentives can include regulatory fast track and priority review provisions, opportunities for early commercialization under Emergency Use Authorization (EUA EUA Examination under anesthesia, see there ) programs, and stockpile purchase orders prior to regulatory approval. The demonstration of treatment safety is a primary endpoint in human studies as human efficacy studies of bioweapon Noun 1. bioweapon - any weapon usable in biological warfare; "they feared use of the smallpox virus as a bioweapon" bioarm, biological weapon anthrax bacillus, Bacillus anthracis - a species of bacillus that causes anthrax in humans and in animals (cattle threats are not permissible. Aethlon recently completed a 24-treatment human safety study at the Apollo Hospital in Delhi, India. In this study, the safety of the Hemopurifier(TM) was documented in health compromised dialysis patients (kidney failure) also infected with Hepatitis-C virus (HCV HCV abbr. hepatitis C virus HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. ). An IDE allows for a device to be used in a clinical study in order to collect data required to support a Pre-market Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application to the FDA. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before a human study can be initiated. The IDE to be submitted by Aethlon will provide detailed clinical plans, including treatment protocols, the Hemopurifier(TM) label indication, patient enrollment procedures, clinical site locations, investigator information, risk analysis, product manufacturing plans and procedures, the submission of relevant publications, and reports related to previous animal, pre-clinical, and clinical studies. About Aethlon Medical Aethlon Medical has developed a first-in-class medical device to treat infectious disease. The device, known as the Hemopurifier(TM), is a broad-spectrum treatment countermeasure against drug and vaccine resistant bioweapons, naturally evolving pandemic pandemic /pan·dem·ic/ (pan-dem´ik) 1. a widespread epidemic of a disease. 2. widely epidemic. pan·dem·ic adj. Epidemic over a wide geographic area. n. threats such as H5N1 Avian Flu, and chronic infectious disease targets including Hepatitis-C (HCV) and the Human Immunodeficiency Virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. (HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. ). Global researcher, Frost & Sullivan, recently awarded the Hemopurifier(TM) the 2006 Technology Innovation Award for its advances in the field of biodefense. Aethlon has also initiated research on a second generation Hemopurifier(TM) 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. 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. |
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