Aethlon Medical Reports Promising Treatment Results In Hepatitis-C Infected Patients
SAN DIEGO--(BUSINESS WIRE)--Sep 17, 2008 - Aethlon Medical, Inc. (OTCBB:AEMD) today announced preliminary data of Hepatitis-C (HCV) infected patients treated with the Aethlon Hemopurifier(R), a medical device designed to assist the immune response in combating infectious disease. 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 studies, robust viral load reductions were observed in tested patients completing a three-treatment Hemopurifier(R) protocol. The resulting data documented that two of three HCV patients tested 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 an overall reduction in follow-on viral load 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(8) viral units per ml of blood. After completion of three Hemopurifier(R) treatments, viral load was reduced an average 57% (final 4.1x10(7) 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. In conclusion, the Hemopurifier(R) treatment of HCV infected patients undergoing dialysis resulted in a net viral load reduction of 60 to 80% with the effects of treatment progressing at least 7 days beyond Hemopurifier(R) treatment.
"The observation of progressive viral load reduction after only three Hemopurifier(R) treatments suggests that extended Hemopurifier(R) treatment applications could effectively inhibit disease progression in HCV patients," stated Aethlon Chairman and CEO, James A. Joyce. "We now plan to further demonstrate a rapid virological response (RVR) through a case study of an HCV patient receiving up to four weeks of Hemopurifier(R) therapy." Studies have shown that rapid virological response (RVR) at week four is a strong predictor of sustained virological response (SVR) in HCV patients. SVR is defined as undetectable viral load for a minimum period of five months after completion of treatment.
The opportunity for new antiviral strategies to fight HCV 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 beneficially respond to the 48-week pegylated interferon-ribavirin treatment standard.
The Hemopurifier(R) is a first-in-class medical device designed to assist the immune response in combating infectious disease by rapidly clearing viruses and immunosuppressive proteins from circulation. The device provides a novel mechanism to complement antiviral therapies by suppressing the emergence of viral strains that cause drug resistance. The Hemopurifier(R) is also positioned to fill the unmet clinical need of treating patients resistant to drug therapy or infected by viral pathogens that are untreatable with drug and vaccine therapy. In HCV care, the device is positioned as an adjunct to improve clinical outcomes of the pegylated interferon-ribavirin treatment standard. Other opportunities in HCV care include the treatment of individuals who fail or are unable to endure standard of care therapy, end-stage renal patients infected with HCV, and HIV patients co-infected with HCV.
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 are presently 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 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 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.
Posted: September 2008