Hemispherx gives FDA new Ampligen data

Hemispherx Biopharma Inc. said it had submitted new information to the U.S. Food and Drug Administration on a drug being developed for chronic fatigue syndrome.

The Philadelphia-based company said that its additional information on Ampligen should address preclinical issues raised in a complete-response letter received late last year.

Hemispherx first applied for use of the experimental drug for CFS in 2007; the application was accepted in July 2008, according to a company financial filing.

The immune-system stimulant Ampligen was discovered at Johns Hopkins University and licensed to Hemispherx Biopharma, and is designed to be system instead of symptom-based.

Company shares advanced 14.7 percent, or 10 cents, to $0.77 in early-afternoon trading.

- Roslyn Rudolph