Medical Device May Lower Hepatitis C Viral Load
Aethlon Medical Announces Completion of 30-Day Hepatitis-C Treatment Study
Posted : Wed, 18 Feb 2009
Author : Aethlon Medical, Inc.
SAN DIEGO – (Business Wire) Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has completed a 30-day treatment case study to further evaluate the safety and efficacy of the Aethlon Hemopurifier® as a candidate treatment for Hepatitis-C Virus (HCV) infection. The Hemopurifier® 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. As in previous studies, which demonstrated robust viral load reductions resulting from three Hemopurifier® treatments administered in a one-week trial, the study enrolled an HCV patient suffering from end-stage renal disease (ESRD) requiring regular kidney dialysis treatment. The study goal was to further demonstrate the Aethlon Hemopurifier® inhibits the progression of HCV in infected ESRD patients. The study protocol provided for 12 Hemopurifier(R) treatments to be administered during the patient’s normally scheduled dialysis treatment. As a result, a 4-hour Hemopurifier® treatment was administered thrice weekly over a period of 30 days. There were no observed adverse events were reported in any of the treatments. The study was conducted at the Fortis Hospital in Delhi, India. Aethlon will disclose viral load and associated data upon receipt from testing laboratories. The insight obtained from the study will help define future clinical protocols and early commercialization strategies. The study data may also be utilized to expand the scope of an IDE submission to the FDA to include the potential use of the Hemopurifier® in the United States as a device designed for the single-use removal of HCV from blood. At present, the focus of Aethlon’s IDE submission has been directed towards high risk bioterror and emerging pandemic threats.
It is estimated that up to 20% of the 1.6 million global ESRD population is infected with HCV. Beyond the treatment of infected ESRD patients, the overall opportunity for the Hemopurifier® is HCV care is significant, as approximately 180 million people worldwide (3% of the world’s population) are HCV infected. According to the World Health Organization (WHO), only 30-50% of infected patients will beneficially respond to the 48-week pegylated interferon-ribavirin treatment standard.
“While we still have much work ahead, I am proud that our research and clinical programs allow us the opportunity to expand the therapeutic filtration industry beyond kidney dialysis and into the much larger infectious disease and cancer markets,” stated Aethlon Chairman and CEO, Jim Joyce. “The continued demonstration of Hemopurifier® safety and effectiveness increases the likelihood that our technology will be available to extend and improve the lives of those suffering from these horrific conditions,” concluded Joyce.
In a previous studies conducted the Fortis Hospital, six ESRD patients received a series of three, 4-hour Hemopurifier® treatments every other day during the course of one week. The treatment regimen also mirrored the patient’s normal kidney dialysis schedule, allowing for the inclusion of the Hemopurifier® without disrupting dialysis treatment. Robust viral load reductions were observed in three HCV patients who completed the three-treatment protocol. Patient #1 had a 95% reduction three days post treatment and 89% reduction seven days post treatment. Patient #2 had a 85% reduction three days post treatment and 50% reduction seven days post treatment, and patient #3 had a 60% reduction three days post treatment and 83% reduction seven days post treatment.
Aethlon additionally disclosed that it soon expects the receipt of viral load and blood chemistry data resulting from a recently completed 30-day HIV treatment case study. The Hemopurifier® is the first medical device to target the treatment of both HIV and HCV, as well as a broad-spectrum of other infectious viral pathogens.
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. The Company’s lead product, the Aethlon Hemopurifier®, is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from circulation. 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® also holds promise in cancer care, as research studies verify the Hemopurifier® effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over sixty-five (65) Hemopurifier® 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 HCV-infected patients who completed a three-treatment protocol during the course of one week.
Research studies have also demonstrated the Hemopurifier® 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).
In additional to therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier® 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 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.
Aethlon Medical, Inc.
Prashant Mehta, Ph.D.
Director of Business Development
Senior VP Finance
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