• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Aethlon Medical Announces ''First-In-Man'' HIV/AIDS Treatment Study

Posted on: Tuesday, 24 June 2008, 09:02 CDT

Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has entered into an agreement to initiate the "first-in-man" clinical study of a medical device to treat the Human Immunodeficiency Virus (HIV) which causes Acquired Immune Deficiency Syndrome (AIDS). The Aethlon Hemopurifier(R) is a medical device created to provide real-time therapeutic filtration of infectious viruses and immunosuppressive proteins. The Hemopurifier(R) holds promise to extend the lives of AIDS patients by removing HIV strains that cause drug failure and reducing the presence of viral proteins that kill-off immune cells. The clinical study was approved by the Institutional Ethics Committee at the Jattinder Gambhir Hospital (J.G. Hospital) in Punjab, India and is anticipated to begin in September.

"The Hemopurifier(R) provides a unique strategy to prolong the lives of AIDS patients who are increasingly becoming resistant to their drug regimens," stated Aethlon Chairman and CEO, James A. Joyce. "In the absence of a curative vaccine, the largest void in HIV care remains a method to slow the proliferation of drug resistant strains produced by the constantly mutating AIDS virus. Clinical validation that the Hemopurifier(R) can fill this void would also establish the opportunity to enhance and extend the benefit of both established and candidate drug therapies," concluded Joyce.

The J.G. Hospital study will evaluate the treatment effectiveness of the Hemopurifier(R) during single-use treatments lasting up to 4 hours as well as sustained benefit resulting from intermittent treatments administered thrice weekly during extended treatment periods. The successful demonstration of treatment benefit would provide Aethlon with an early commercialization opportunity within India's practitioner driven medical device marketplace. With an estimated 5.7 million people living with HIV/AIDS, India has the highest HIV/AIDS prevalence in the world according to UNAIDS. Among 15-49 year olds, an estimated 5.2 million are living with the disease, according to India's National AIDS Control Organization (NACO).

Aethlon further disclosed that two candidates remain to be enrolled and treated to complete human safety studies currently being conducted at the Fortis Hospital in Delhi, India. Completion of the study is anticipated, but not required to occur, in advance of the HIV treatment studies to be conducted at the J.G. Hospital. Aethlon previously demonstrated treatment safety of the Hemopurifier(R) in a 24-treatment study conducted at the Apollo Hospital, also located in Delhi.

About Aethlon Medical

Aethlon Medical is the developer of the Hemopurifier(R), a first-in-class medical device designed to treat infectious disease. The Hemopurifier(R) provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and is positioned to address the treatment of drug and vaccine resistant viruses. Additionally, the device holds promise in cancer care, as research studies have verified the Hemopurifier(R) is able to capture immunosuppressive particles secreted by tumors. The Hemopurifier(R) is designed to act both as a stand-alone therapeutic, and as an adjunct treatment to enhance clinical benefit of established 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(R) in capturing from circulation the viruses that constitute pandemic threats, including H5N1 Avian Influenza (bird flu), and Dengue Hemorrhagic Fever (DHF) from circulation. The company is conducting studies to support the use of the Hemopurifier(R) 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 demonstrated the safety of the Hemopurifier(R) 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) to advance the Hemopurifier(R) as a broad-spectrum treatment countermeasure against category "A" bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier(R) technology is available 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: Business Wire

More News in this Category