Category: Investment, Biotech, Biodefense
New Development for Treatment and Testing of Hepatitis C virus (HCV)
Aethlon Medical (OTCQB: AEMD) Reports FDA approval of IDE to Treat Hepatitis C (HCV) Patients
Abbott Laboratories (NYSE: ABT) Announces First U.S. Food and Drug Administration (FDA)approved hepatitis C genotyping test is now available in the U.S.
U.S. Preventive Services Task Force Issues Final Recommendation Statement on Screening for Hepatitis C Virus Infection in Adults
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Point Roberts, WA, New York, NY - June 27, 2013 (Investorideas.com newswire) Investorideas.com, an investor research portal specializing in investing ideas in leading sectors including biotech and medical technology stocks, discusses recent news and developments for the treatment and testing of Hepatitis C virus (HCV) . Aethlon Medical, Inc. (OTCQB: AEMD) reported FDA approval of an Investigational Device Exemption (IDE) to treat Hepatitis C (HCV) patients and Abbott Laboratories (NYSE: ABT) announced the first U.S. FDA approved hepatitis C genotyping test is now available in the U.S. to help physicians improve patient care.
According to the CDC, about 3 million adults in the US are infected with the hepatitis C virus, most are baby boomers. Hepatitis C is a serious virus infection that over time can cause liver damage and even liver cancer. Early treatment can prevent this damage. Too many people with hepatitis C do not know they are infected, so they don't get the medical care they need. Once infected with the hepatitis C virus, nearly 8 in 10 people remain infected for life.
Earlier this week the U.S. Preventive Services Task Force made headlines as it made statements recommending screening for hepatitis C virus (HCV) infection in persons at high risk for infection. The USPSTF also recommended offering one-time screening for HCV infection to adults born between 1945 and 1965.
"Millions of people in the United States are infected with hepatitis C, and many are unaware of their condition, in large part because they may not have any symptoms," says Task Force member Kirsten Bibbins-Domingo, Ph.D., M.D. "Hepatitis C infection is a leading cause of liver damage, liver cancer, and liver transplants in the United States. Screening for hepatitis C can help people who are infected live longer, healthier lives."
Aethlon Medical, Inc. (OTCQB: AEMD), reported this week that the FDA has approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in the United States. The Hemopurifier ® is a first-in-class medical device that targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation.
Under the feasibility study protocol, Aethlon will enroll ten end stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease conditions.
The FDA approved Hemopurifier therapy feasibility study calls for a single-site enrollment of ten HCV-infected end-stage renal disease (ESRD) patients who have not received any pharmaceutical therapy for their HCV infection for at least 30 days. The protocol consists of a control phase which consists of three consecutive standard dialysis treatments during week one followed by the inclusion of the Hemopurifier during a total of six dialysis sessions conducted during weeks two and three. The rate of adverse events observed during the Hemopurifier therapy phase will be compared to the rate experienced during the control phase. Per-treatment changes of viral load will be observed through quantitative PCR analysis. Additionally, Aethlon may also choose to quantitate HCV viral copies captured within the Hemopurifier during each treatment session.
Last week Abbott (NYSE: ABT) reported it has introduced the first FDA-approved hepatitis C virus (HCV) genotyping test for patients in the United States. Abbott's fully automated RealTime HCV Genotype II test determines the specific type or strain (referred to as the genotype) of the HCV virus present in the blood of an HCV-infected individual. Genotyping the HCV virus provides physicians with important information they can use to create a personalized, targeted diagnosis and treatment path to improve clinical outcomes.
About Aethlon Medical (OTCQB: AEMD)
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT product pipeline includes the Aethlon Hemopurifier to address infectious disease and cancer, and a medical device being developed under a 5-year contract with DARPA to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
Abbott Laboratories (NYSE: ABT)
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000.
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