You are here
Randomization, Placebo-Controlled Dosage Stage of Phase III Trial Completed for Ampligen in Chronic Fatigue Syndrome
The clinical trial is a multi-center, double-blind, randomized, placebo-controlled Phase 3 pivotal study of the efficacy and safety of the experimental agent Ampligen® versus placebo in patients with severely debilitating Chronic Fatigue Syndrome (CFS).
The Company believes that efficacy 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. Efficacy may be established by showing a medically significant increase (≥ 6.5%) in mean exercise duration (baseline compared to week 40) that is statistically significant (p≤ 0,05) using analysis of covariance of log10 transformed data with Baseline ETT duration as covariate. The Company will also analyze the median absolute changes in ETT duration between termination and baseline using the Mann Whitney test. The secondary endpoints of the study are various other indices of physical performance and cognitive activity.
About Chronic Fatigue Syndrome
CFS is defined by various governmental agencies as a serious debilitating disease in which patients suffer complex symptoms, including profoundly disabling fatigue, flu-like symptoms, headaches, sore throat, joint and muscle pain, mental fogginess, depression and sleep disorders. The U.S. Center for Disease Control and Prevention has added CFS to its top priority list of emerging infectious diseases. CFS is estimated to affect over 500,000 people in the U.S., and an equal number in Europe. At present, there is no other specific treatment available for CFS and no alternative drug appear to be under development in recognized clinical trials.
Ampligen® is an experimental, double stranded RNA drug acting potentially 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. The experimental product is currently in a Phase 3 clinical trial for the potential treatment of CFS and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS. Treatment IND status for Ampligen® and CFS has already been recognized by various regulatory bodies.
Source: Hemispherx Biopharma, Inc.