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AMPLIGEN STUDY

The Enlander practice is pleased to announce in his New York Manhattan office that we are cooperating with Hemispherx Corporation in a study of AMPLIGEN in the treatment of Chronic Fatigue Syndrome (ME/CFS),
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Ampligen is undergoing FDA approval as a treatment for ME/CFS.Only five other centers have been chosen in the United States The study is self funded by patients and is not covered by insurance. We suggest that patients Google AMPLIGEN so that they are familiar with the medicine and the study. We are the only center in the New York Metropolitan area that is licensed to do the AMPLIGEN study.

Ampligen, also known as poly I:poly C12U, is an experimental immunomodulatory double stranded RNA drug developed by Hemispherx Biopharma of Philadelphia, Pennsylvania. Ampligen was first synthesized in the 1970s and has been proposed and tested as a treatment forillnesses including Myalgic Encephalomyelitis / chronic fatigue syndrome (ME/CFS) and acquired immunodeficiency syndrome (AIDS).

What Ampligen Does:

Ampligen is believed to work by jump-starting your body's natural anti-viral pathway and regulating levels of RNase L (a substance in your cells that attacks viruses), which can be high in people with ME/CFS. It's also been shown to inhibit tumor-cell growth.

Ampligen for Chronic Fatigue Syndrome:

In clinical trials, Ampligen has been shown to improve cognition, exercise tolerance, neuropsychological health and overall function in people with ME/CFS; decrease activity of HHV-6 (a virus believed to be linked to ME/CFS); and decrease RNase L activity.

Hemispherx reports that it completed a Phase III clinical trial for CFS in 2004 and filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) to market and sell Ampligen for the treatment of CFS,[1] but this was rejected in December 2009 because the FDA concluded that the two RCTs "did not provide credible evidence of efficacy. This year the FDA trial have been reopened and a study of the efffects of Ampigen in cases of Myalgic Encephalomyelitis / chronic fatigue syndrome . Five Ampligen centers were chosen in the United States; alphabetically , Bateman in Salt lake City, Utah, Enlander in Manhattan New York,, Klimas in Miami Florida, Lapp in North Carolina, andPeterson in Reno, Nevada. Patients who are interested should contact us and we will review their condition for inclusion in the study. Ampligen is infused intravenously twice weekly for a period of six months.

Hemispherx Biopharma is a small company and cannot completely underwrite the cost of the study, patients are required to defray the cost of the study, the cost is approximately $1,200 per month.