July 8, 2008
July 8 – After 30 years in development and testing, the experimental “antiviral/immune modulatory” drug AmpligenR has been accepted by the FDA for review as potentially the first prescription drug approved in the U.S. for treatment of ME/CFS – specifically for certain patients with severe ME/CFS.
Delivered intravenously, typically twice weekly over a year or more, AmpligenR (AMPLified GENetic activity) has been available in Belgium and Canada for ME/CFS and HIV treatment since 1996.
AmpligenR (polyI:polyC12U) - still allowed only in specific clinical trial settings conducted under U.S. governmental authorization - is termed “a nucleic acid drug,” designed to “modulate” the body’s immune system. Its mechanism of action in ME/CFS “is not entirely clear,” but it is thought to act on two enzyme systems so as to help the immune system destroy viral RNA and speed the death of virus-affected cells. In particular it may “downregulate” an anti-viral pathway which research suggests has become “upregulated” in certain ME/CFS patients (the 2-5 Synthetase/RNase L anti-viral pathway).
The drug’s maker – Philadelphia-based Hemispherx Biopharma, submitted a New Drug Application to the FDA in 2007, and had been asked to answer a series of questions. The FDA’s acceptance of the drug for safety/efficacy review was based on receipt of the requested data. The maker reportedly suggests it is also researching oral delivery of the drug.
A "Who's-Who" of the world’s leading ME/CFS specialists have participated in AmpligenR trials over the years.
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