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Aethlon Medical Initiates First Clinical Study Of a Medical Device to Treat HIV/AIDS Patients

Posted on: Monday, 29 September 2008, 09:00 CDT

Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has initiated patient enrollment in the "first-in-man" clinical study of a medical device to treat the Human Immunodeficiency Virus (HIV), the disease that causes Acquired Immune Deficiency Syndrome (AIDS). The device, known as the Aethlon Hemopurifier(R), assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins. The Hemopurifier(R) has previously demonstrated rapid viral load reduction in Hepatitis-C patients, and based on research data, is the most advanced broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The HIV treatment studies are being conducted at the Jattinder Gambhir Hospital (J.G. Hospital) in Punjab, India, and the Bhvani Hospital in Bihar, India. In the studies, up to six HIV-infected patients will be administered daily Hemopurifier(R) treatment for a period up to nine consecutive days.

"Based on our recent Hepatitis-C treatment observations, I am increasingly confident that our Hemopurifier(R) will demonstrate similar effectiveness in HIV studies," stated Aethlon Chairman and CEO, Jim Joyce. "If correct, the Hemopurifier(R) will advance HIV care by offering a treatment option that extends life for patients no longer responsive to drug therapy, and enhances the benefit of drug regimens by inhibiting the proliferation of HIV strains that cause drug resistance," concluded Joyce.

In HIV care, the Hemopurifier(R) is designed to provide both an antiviral and immunotherapeutic mechanism of action. The goal of treatment is to inhibit viral replication through the rapid clearance of all strains of infectious HIV, and to augment the immune response by eliminating circulating gp120, a protein that sheds from the surface of HIV to kill-off immune cells necessary to fight infection.

On September 17th, Aethlon Medical disclosed preliminary data resulting from Hepatitis-C (HCV) infected patients being treated with the Hemopurifier(R). The HCV treated patients were among end-stage renal disease (kidney dialysis) patients enrolled in human safety studies being conducted at the Fortis Hospital, in Delhi, India. In the HCV studies, an average viral load reduction of 82% was observed in patients after just three Hemopurifier(R) treatments. The study data documented that two of three patients infected with HCV responded with measurable viral load reductions during the course of three 4-hour Hemopurifier(R) treatments. The three treatments were administered during scheduled dialysis therapy every other day over the span of five days. The third patient showed both increases and decreases in viral load during the course of treatment, but demonstrated significant overall reduction of viral load in follow-on tests. Given the small sample size, viral load data was averaged for all 3 patients. Average initial HCV viral load was 3.13 x 10 to the eighth viral units per ml of blood. After completion of three Hemopurifier(R) treatments, viral load was reduced an average 57% (final 4.1x10 to the seventh IU/ml). The stepwise drop in HCV viral load averaged 36% per treatment. Follow-on testing indicated that HCV viral load was 60% lower than initial viral load values when measured three days after final Hemopurifier(R) treatment, and at seven days post treatment, viral load declined to 82% below starting viral load values. Additionally, none of the patients were being treated with antiviral drug therapy. Viral load measurements were performed with real-time quantitative polymerase chain reaction (RT-PCR). Control samples were measured in duplicate while treatment samples were generally measured in triplicate.

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 has also conducted studies that 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 and pandemic threats, while international initiatives are directed toward the treatment of 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 and pandemic 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, which can be accessed at www.SEC.gov.

Source: Business Wire

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