6. januar 2009

Will Ampligen finally be approved?

Fra About.com by Adrienna Dellwo

While millions of people with chronic fatigue syndrome have waited decades for better treatments, a drug called Ampligen (poly I: poly C12U) has languished in the "experimental" stage for 30 years.

Then, in October 2007, Ampligen's manufacturer, Hemispherex Biopharma Inc., put in a New Drug Application for Ampligen as the first ever FDA approved treatment for ME/CFS. In July, the company responded to questions sent back by the FDA, and the application was officially accepted. Now, it's just a matter of time before we hear yea or nay. The decision should be out sometime this year.

Ampligen is an immume-system modulator that works 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. Studies show it's more effective and has far fewer side effects than other drugs in its class. Ampligen has also been studied as a possible treatment for certain types of cancer, AIDS, and avian flu.

This drug has been available to certain U.S. clinics for several years, and there's a lot of evidence (both clinical and experiential) showing that it works. Some doctors claim they've seen improvement in 80% of people with ME/CFS who take Ampligen, and significant improvement in about 50%. A lot of seriously disabled people have even been able to go back to work because of it, they say. Side effects are reportedly mild, and oddly enough include flu-like symptoms, dizziness and confusion. (After living with ME/CFS, would you even recognize those as side effects?)

Here's more info from the manufacturer: Ampligen, from Hemispherex Biopharma

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