Hemispherx Biopharma Inc. is till trying to move toward approval for Ampligen as a chronic fatigue syndrome (CFS) treatment. The company says it has given new preclinical information to the FDA.

When the FDA announced in December that it was not approving Ampligen, it made recommendations to the company about what was needed to improve the drug's chances of approval down the road. Hemispherx says the data it has just submitted should sufficiently address some of the FDA's concerns.

Ampligen is currently not approved for any use in the US, but some doctors are prescribing it for their chronic fatigue syndrome patients through a special program.

In related news, Hemispherx has given an unrestricted grant to the International Association for Chronic Fatigue Syndrome to assist the organization with research, advocacy and its effort to establish guidelines for treating chronic fatigue syndrome.

What Ampligen Is:

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/ME), 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 CFS/ME treatment and the decision is expected in June 2009. If it's approved, Ampligen will be the first approved treatment for this condition.

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 CFS/ME. It's also been shown to inhibit tumor-cell growth.

Ampligen for CFS/ME:

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

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.

Ampligen Side Effects:

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.