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Aethlon Medical Announces Data Supported Strategy to Increase Hepatitis-C (HCV) Cure Rates

March 25, 2009

SAN DIEGO, March 25 /PRNewswire-FirstCall/ — Aethlon Medical, Inc. (OTC Bulletin Board: AEMD) today announced clinical data that supports the advancement of the Aethlon Hemopurifier(R) as an adjunct therapy to increase Hepatitis-C (HCV) cure rates. The Hemopurifier(R) is a first-in-class medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins. In HCV care, the device inhibits viral replication through selective elimination of HCV in circulation and assists to preserve immune cells by removing toxic proteins shed from the surface of HCV.

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Aethlon disclosed that data resulting from over 20 HCV treatments indicates an average viral load reduction of 41% during each four-hour Hemopurifier(R) treatment. In the studies, average pre-treatment viral load of 22,868,000 HCV virus copies/ml blood (cpm) was reduced on average by 9,300,000 cpm during the course of each treatment. Based on this data, Aethlon predicts that short-term continuous Hemopurifier(R) treatment can reduce viral load to low to undetectable levels, thus improving the likelihood that HCV patients achieve a sustained virological response (SVR) from the current interferon-ribavirin standard of care and other candidate therapies. HCV infection is considered cured when SVR extends beyond six months. At present, less than 50% of HCV patients respond to interferon-ribavirin therapy. Additionally, there is a direct correlation between low viral load at onset of interferon-ribavirin therapy and increased cure rates. Based on data analyzed from each four-hour Hemopurifier(R) treatment, Aethlon projects that a patient with a high viral load of 7 million iu/ml would be reduced to undetectable HCV levels after approximately three days of continuous Hemopurifier(R) treatment. This corresponds to a 4.06 log reduction or an 11,000-fold decrease in viral load. An HCV patient with a moderate viral load of 2 million iu/ml would be projected to reach undetectable levels in approximately 2.5 days of continuous treatment. All of the studies were conducted in highly health compromised HCV infected patients who suffer from end-stage renal disease (ESRD) requiring regular kidney dialysis treatment. In these treatment studies, the Hemopurifier(R) inhibited the progression of HCV infection in ESRD patients when included during dialysis treatment administered thrice weekly for four-hours. The studies were conducted at the Fortis Hospital in Delhi, India.

About Hepatitis-C Virus

HCV is a leading cause of chronic liver disease and liver transplants. The World Health Organization (WHO) estimates that nearly 180 million people worldwide, or approximately 3% of the world’s population, are infected with HCV. 130 million of these individuals are chronic HCV carriers who are at increased risk of developing liver cirrhosis or liver cancer, approximately 15 million of whom are in the United States, Europe and Japan. The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million were chronically infected. Approximately 2.6%, or 71,000, of these HCV patients are treated each year. Although chronic HCV infection varies greatly in its course and outcomes, 70% of chronically infected patients develop some form of chronic liver disease, including, in some cases, cirrhosis or liver cancer.

In the United States, the current standard of care for the treatment of HCV is a combination of pegylated interferon and a nucleoside analog named ribavirin. According to WHO, treatment with interferon in combination with ribavirin is effective in 30% to 50% of patients, while interferon alone is effective in approximately 10% to 20% of patients. In HCV genotypes 1a and 1b, which account for over 70% of HCV infections in the US, less than 50% of these patients respond to standard therapy consisting of pegylated interferon plus ribavirin. In addition, these therapies have serious side effects that include fatigue, bone marrow suppression, anemia and neuropsychiatric effects. As a result of the limited benefits and serious side effects of existing therapies, significant value is placed on promising antiviral strategies to fight HCV. The Aethlon Hemopurifier(R) is positioned to improve the benefit of the current interferon-ribavirin standard of care, as well as other candidate HCV drug therapies demonstrating promise in clinical studies.

About Aethlon Medical

Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. Aethlon’s lead product, the Hemopurifier(R), is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from the human circulatory system. The device targets to inhibit disease progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV), and serves as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The Hemopurifier(R) also holds promise in cancer care, as research studies verify the Hemopurifier(R) effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over sixty-five (65) Hemopurifier(R) treatments (representing approximately 260 hours of treatment time) have been conducted in multi-site studies at the Apollo Hospital, Fortis Hospital, and Sigma New-Life Hospital in India. The studies enrolled end-stage renal disease (ESRD) patients infected with either HCV or HIV. In addition to establishing treatment safety, robust viral load reductions have been reported in both HCV and HIV infected individuals.

Research studies have also demonstrated the Hemopurifier(R) is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of world’s deadliest bioterror and pandemic threats. These include: Dengue hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF), Lassa hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), the reconstructed 1918 influenza virus (r1918), West Nile virus (WNV), and Vaccinia and Monkeypox (MPV), which both serve as models for human smallpox infection. The studies were conducted with the assistance of researchers representing: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID); The Centers for Disease Control and Prevention (CDC); The National Institute of Virology (NIV); The Battelle Biomedical Research Center (BBRC); and The Southwest Foundation for Biomedical Research (SFBR).

Beyond therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier(R) technology platform to establish a pipeline of clinical and research diagnostic products and services. Additional information regarding Aethlon Medical 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 capability of the Hemopurifier(R) to reduce viral loads and other disease conditions, 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, Inc.


Source: newswire



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