Ampligen (polyu I: poly C12U) in an experimental anti-viral, immune-system modulating drug that's been in the works for more than 30 years. It's been studied as a possible treatment for multiple conditions, including chronic fatigue syndrome (CFS or ME/CFS), HIV/AIDS, certain types of cancer, and, most recently, both avian flu (H5N1) and swine flu (H1N1).
Ampligen's manufacturer, Hemispherx Biopharma Inc., has applied for FDA approval of Ampligen as an ME/CFS treatment and the decision is expected in June 2009. If it's approved, Ampligen will be the first approved treatment for this condition.
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.
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.
According to Ampligen's manufacturer, Hemispherx Biopharma Inc., more than 40,000 doses of Ampligen were given to about 500 patients in clinical trials at more than 20 U.S. clinics. One of those clinics, the Hunter-Hopkins Center, says 80% of its patients improved on Ampligen, and 50% improved significantly.
Ampligen is administered intravenously (I.V.). In trials and under conditional permits by the FDA, patients typically have received 400mg of the drug twice a week. Hunter-Hopkins recommends at least 12 months of therapy, and 18 months for the severely ill.
Possible side effects of Ampligen include:
- Mild flushing
- Tightness of the chest
- Rapid heartbeat
- Anxiety
- Shortness of breath
- Feeling hot
- Sweating
- Nausea
- Liver enzyme level changes
- Diarrhea
- Itching
- Low blood pressure
- Rash
- Arrhythmias
- Low white blood cell count
- Dizziness
- Confusion
Some patients have flu-like symptoms for a few hours after receiving a dose of the drug, and the company says these effects typically went away after several months of treatment.
Sources:
Clinical Infectious Diseases. 1994 Jan;18 Suppl 1:S88-95. "A controlled clinical trial with a specifically configured RNA drug, poly(I).poly(C12U), in chronic fatigue syndrome."
Clinical Infectious Diseases. 1994 Jan;18 Suppl 1:S96-104. "Upregulation of the 2-5A synthestase/RNase L antiviral pathway associated with chronic fatigue syndrome."
In Vivo. 1994 Jul-Aug;8(4):599-604. "Changes in the 2-5S synthetase/RNase L antiviral pathway in a controlled clinical trial with poly(I)-poly(C12U) in chronic fatigue syndrome."
