Healthcare Industry News: antiviral
News Release - November 1, 2007
Aethlon Medical Initiates Human Clinical StudiesSAN DIEGO--(HSMN NewsFeed)--Aethlon Medical, Inc. (OTCBB:AEMD ), a pioneer in developing medical devices to treat infectious disease, announced today that it has initiated clinical testing the Aethlon Hemopurifier® in human studies being conducted at the Fortis Hospital in Delhi, India. The study, approved by the Ethics Committee for Research at Fortis Hospital, will evaluate safety of the Hemopurifier® in up to ten patients with end-stage renal disease. The Hemopurifier® is a first-in-class medical device to treat infectious disease. The device removes infectious viruses and immunosuppressive proteins from circulation, thus allowing the natural immune response a greater opportunity to overcome viral infection.
“The launch of this study is a significant milestone as its successful completion will trigger our commercialization efforts in India,” stated Aethlon Chairman and CEO, James A. Joyce. Commercialization of the Hemopurifier® in India will be based on obtaining sufficient clinical data to drive practitioner confidence and acceptance in the marketplace. At present, government regulatory challenges in India do not address devices such as the Hemopurifier®. Pending the successful completion of the study, Aethlon will focus on medical conditions of greatest concern to the people of India. Such conditions include Dengue Hemorrhagic Fever (DHF), and HIV/AIDS. “We believe the further demonstration of safety combined with supporting data from our numerous research collaborations will provide the opportunity to treat India’s most significant infectious disease threats,” concluded Joyce.
The principal investigator of the study is Dr. Vijay Kher, who serves as Director of Nephrology at Fortis Hospital. Previously, Dr. Kher acted as principal investigator of a Hemopurifier® study conducted at the Apollo Hospital in Delhi. The Apollo study documented initial safety of the Hemopurifier®, and provided early efficacy observations during 24-treatments administered to health compromised dialysis patients co-infected with Hepatitis-C (HCV).
In a recent collaboration with researchers at Government of India’s National Institute of Virology (NIV), it was documented that the Hemopurifier® is highly efficient in capturing infectious dengue virus from blood. In preliminary studies, the Aethlon Hemopurifier(R) removed up to 90% of live dengue virus in 30 minutes. The NIV is India's leading infectious disease research center and a collaborating laboratory of the World Health Organization (WHO). Dengue, a considerable health threat in India, is one of the world's most prevalent infectious diseases with an estimated 50 to 100 million cases each year. As the disease is not treatable with a vaccine or antiviral drugs, Aethlon believes the Hemopurifier® may provide clinical benefit by rapidly reducing viral load in infected patients, thus allowing the immune response a greater opportunity to overcome infection. Aethlon is also in discussions with the National AIDS Research Institute (NARI) regarding the treatment of HIV-infected patients. NARI is the government agency overseeing India's HIV infected population. Last year, UNAIDS, the United Nations agency, estimated that India had 5.7 million HIV cases, the largest infected population of any individual country.
About Aethlon Medical
Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device to treat infectious disease. The Hemopurifier® 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 (HIV). Collaborative studies to demonstrate utility of the Hemopurifier® are being conducted with researchers at the Government of India’s National Institute of Virology (NIV), 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). Aethlon recently demonstrated safety of the Hemopurifier® in a 24-treatment human study and has received approval to continue further human studies at The Fortis Hospital in India. The Company has also 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 can be accessed online 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.
Source: Aethlon Medical
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