Ampligen

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Chronic Fatigue Syndrome Treatment - Will Ampligen Finally Be

Approved?

Tuesday January 6, 2009

New Drugs of 2009 Series: Ampligen

While millions of people with chronic fatigue syndrome (CFS or

ME/CFS) 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