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
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
CFIDS Chronicle later this year
when the manufacturer presents data from the clinical trial.