Science & Technology
Tue, January 20, 2009Mon, January 19, 2009Sat, January 17, 2009Fri, January 16, 2009Thu, January 15, 2009Wed, January 14, 2009Tue, January 13, 2009Aethlon Medical Nears Completion of First Medical Device Study to Treat HIV/AIDS
Published in Science and Technology on Thursday, January 15th 2009 at 3:10 GMT, Last Modified on 2009-01-15 03:12:10 by Market Wire
SAN DIEGO--([ BUSINESS WIRE ])--Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it is nearing completion of 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 recently initiated treatment with the Aethlon Hemopurifier® as part of a 30-day case study being conducted at the Jattinder Gambhir Hospital (J.G. Hospital) in Punjab, India. The study protocol, which calls for the administration of up to twelve Hemopurifier® treatments, is scheduled to be completed on January 23rd. The study goal is to demonstrate that the Hemopurifier® can safely and effectively reduce viral load and trigger replenishment of CD4 immune cells in the absence of drug therapy.
The Hemopurifier® is a therapeutic filtration device that serves as an artificial adjunct to the immune system. The device has been designed to improve infectious disease treatment outcomes through real-time clearance of infectious viruses and immunosuppressive particles. In HIV care the Hemopurifier® targets all circulating strains of infectious HIV, including those varieties that cause patients to fail antiviral drug regimens. Additionally, the device preserves the immune response through the removal of gp120 and other toxic proteins shed by HIV to kill-off immune cells, the hallmark of AIDS.
"The antiviral and immunotherapeutic attributes of our Hemopurifier® offer a realistic strategy for managing a broad-spectrum of infectious disease conditions," stated Jim Joyce, Chairman and CEO of Aethlon Medical. "In caring for those infected with HIV, we plan to enhance the benefit of drug regimens by curbing the proliferation of viral strains that cause drug resistance, and we seek to extend and improve the lives of individuals once they no longer respond to drug therapy," concluded Joyce.
In a previous infectious disease studies, treatment with the Hemopurifier® resulted in robust viral load reductions in Hepatitis-C (HCV) infected patients who completed a treatment protocol of three, 4-hour Hemopurifier® 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®, a first-in-class medical device designed to treat infectious disease. The Hemopurifier® 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® is able to capture immunosuppressive particles secreted by tumors. The Hemopurifier® 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® 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® 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® 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® as a broad-spectrum treatment countermeasure against category "A" bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier® 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.
