Aethlon Medical Announces Approval of Clinical Study.SAN DIEGO -- Please note: throughout the release, the product name should read Hemopurifier[R] (sted HemopurifierAE). The corrected release reads: AETHLON MEDICAL ANNOUNCES APPROVAL OF CLINICAL STUDY Aethlon Medical, Inc., (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AEMD) announced today that it has received approval to initiate clinical testing of the Hemopurifier[R] in human studies to be conducted at the Fortis Hospital (www.fortishealthcare.com) in Delhi, India. The study, approved by the Ethics Committee for Research at Fortis Hospital, will evaluate safety of the Hemopurifier[R] in up to ten patients with end-stage renal disease End-stage renal disease (ESRD) Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity. Mentioned in: Chronic Kidney Failure end-stage renal disease . Pending patient accrual, the study is expected to begin in August. Dr. Vijay Kher, Director of Nephrology at Fortis has agreed to be the principal investigator of the study. Previously, Dr. Kher acted as principal investigator of a Hemopurifier[R] study conducted at the Apollo Hospital in Delhi. The Apollo study documented initial safety of the Hemopurifier[R], and provided early efficacy observations during 24-treatments administered to health compromised dialysis patients co-infected with Hepatitis-C (HCV HCV abbr. hepatitis C virus HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. ). The Fortis study supports Aethlon's strategy to pursue early treatment and commercialization opportunities in India. Aethlon will focus on viral conditions of greatest concern to Indian citizens, and opportunities that offer treatment access to the Hemopurifier[R] within India's growing medical tourism industry. Targeted conditions may include Dengue Hemorrhagic Fever (DHF DHF dihydrofolate or dihydrofolic acid. ), HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome , and HCV. At present, regulatory barriers specific to the Hemopurifier[R] do not exist in India. As a result, introduction of the Hemopurifier[R] into the marketplace will be based on obtaining sufficient clinical data to drive practitioner acceptance in the marketplace. As with previous pre-clinical and clinical programs in India, Aethlon will seek additional support and guidance from the Indian Council of Medical Research The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. (ICMR). Aethlon may also consult with 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. ) on protocol design and will provide the FDA with clinical data obtained from studies as a means to potentially augment clinical efforts to advance the Hemopurifier[R] as a broad-spectrum countermeasure against bioterror threats in the United States. About Aethlon Medical Aethlon Medical is the developer of the Hemopurifier[R], a first-in-class medical device to treat infectious disease. The Hemopurifier[R] addresses the largest opportunity in infectious disease, the treatment of drug and vaccine resistant viruses. Regulatory and commercialization initiatives in the United States are focused on bioterror threats, while international initiatives are directed towards naturally evolving pandemic threats, and chronic infectious disease conditions 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). Collaborative studies to demonstrate utility of the Hemopurifier[R] are being conducted with researchers at the Government of India's National Institute of Virology (NIV), The Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC), The United States Army Medical Research Institute of Infectious Diseases The United States Army Medical Research Institute of Infectious Diseases (USAMRIID, pronounced you-SAM-rid) is a military research institute for medicine based at Fort Detrick, Frederick, Maryland used for research of infectious disease that may have defensive applications against (USAMRIID USAMRIID United States Army Medical Research Institute of Infectious Diseases (US DoD) ), and The Southwest Foundation for Biomedical Research Southwest Foundation for Biomedical Research (SFBR) is a large private research institute located in San Antonio Texas. With 400 staff and a 397 acre campus, SFBR is "one of the world's leading independent biomedical research institutions. (SFBR). Aethlon has previously demonstrated safety of the Hemopurifier[R] in a 24-treatment human study, and most recently submitted an 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 U.S. Food and Drug Administration (FDA) requesting permission to initiate human studies of the Hemopurifier[R] as a treatment countermeasure against select category "A" bioterror threats. Additional information on Aethlon Medical and its Hemopurifier[R] technology can be accessed 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. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion