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Aethlon Medical Completes First Medical Device Study to Treat HIV/AIDS
SAN DIEGO--(BUSINESS WIRE)--Jan. 26, 2009--Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has completed the "first-in-man" study of a medical device to treat Human Immunodeficiency Virus (HIV), the disease that causes Acquired Immune Deficiency Syndrome (AIDS). In the study, an HIV-infected individual completed a twelve treatment study of the Aethlon Hemopurifier(R) administered thrice weekly over the course of 30-days. The Hemopurifier(R) is a therapeutic filtration device that serves as an artificial adjunct to the immune system. In HIV care the Hemopurifier(R) targets the clearance of all circulating strains of infectious HIV, including those varieties that cause patients to fail antiviral drug regimens. Additionally, the device assists to preserve immune response through the removal of gp120 and other toxic proteins shed by HIV to kill-off immune cells, the hallmark of AIDS. The study was conducted at the Sigma New Life Hospital in Punjab, India. Initial viral load and immune cell data resulting from the study are expected to be available for disclosure in mid-February.
"Based on previous treatment outcomes in Hepatitis-C patients, we are cautiously optimistic that the data resulting from our first HIV study will also prove to be positive," stated Jim Joyce, Chairman and CEO of Aethlon Medical. "The principal investigator of our study has reported all twelve Hemopurifier(R) treatments were completed without any observed adverse events, and that the patient feels an improved sense of well being, including increased energy and appetite," concluded Joyce.
In a previous infectious disease study, treatment with the Hemopurifier(R) resulted in robust viral load reductions in Hepatitis-C (HCV) infected patients who completed a treatment protocol of three, 4-hour Hemopurifier(R) treatments every other day during the course of one week. The Study was conducted at the Fortis Hospital in Delhi, India.
Patient #1 had a 95% reduction three days post treatment and 89% reduction seven days post treatment. The initial viral load for patient 1 was 5.3 x 10(5) viral units per ml of blood (IU/ml). Patient 1's viral load seven days post treatment was 5.7 x 10(4) IU/ml.
Patient #2 had a 85% reduction three days post treatment and 50% reduction seven days post treatment. The initial viral load for patient 2 was 9.2 x 10(6) IU/ml. Patient 2's viral load seven days post treatment was 4.6 x 10(6) IU/ml.
Patient #3 had a 60% reduction three days post treatment and 83% reduction seven days post treatment. The initial viral load for patient 3 was 3.0 x 10(8) IU/ml. Patient 3's viral load seven days post treatment was 5.1 x 10(7) IU/ml. All 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 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 have been 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 has demonstrated safety of the Hemopurifier(R) in a 24-treatment human study at the Apollo Hospital in Delhi, India, and in an 18-treatment study at the Fortis Hospital, also located in Delhi. The company has also 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.
CONTACT: Aethlon Medical, Inc.
Jim Frakes, Senior VP Finance
858-459-7800 x300
jfrakes@aethlonmedical.com or
Jim Joyce, Chairman, CEO
858-459-7800 x301
jj@aethlonmedical.com
Source: Aethlon Medical, Inc.
-JM2C
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