Ampligen Update

The Phase 3 clinical trial to determine the effectiveness and safety of using Ampligen to treat chronic fatigue syndrome has concluded. Ampligen is an experimental, double-stranded RNA drug that may potentially act as an immunomodulator and antiviral. Based on in vitro studies, Ampligen is believed to stimulate the immune system as well as inhibit the virus directly.

Hemispherx Biopharma, Inc., the manufacturer of the drug, announced the completion of the randomization and placebo-controlled dosage stage of its Phase 3 clinical trial on January 30. The company expects to present clinical data from this study in the second quarter of 2004.

In the press announcement, Hemispherx Biopharma says it believes that the efficacy of Ampligen “will be established by showing medically and statistically significant improvement of the primary endpoint, which is improved physical performance as measured by Treadmill Exercise Tolerance Testing (ETT): Duration.” Other indices of physical performance and cognitive activity will be used as secondary endpoints of the study.

Look for more information on Ampligen in The CFIDS Chronicle later this year when the manufacturer presents data from the clinical trial.