The Food and Drug Administration recently denied Ampligen, ‘fast track’ status, a process aimed at shortening the length of time it takes for important new drugs to get to the market. Ampligen is an experimental immune drug in clinical trials in the United States and Europe.
The news is not all bad, however. Preliminary findings for Ampligen were released at the end of January, 2001. The findings, presented at the American Association for Chronic Fatigue Syndrome Conference in Seattle, Washington, described significant changes in cognitive deficit, vitality and activity scores.
The objective of the study was to review clinical endpoints including Karnofsky Performance Scores (KPS) and Cognitive Function data derived from an expanded access treatment protocol using Ampligen for the treatment of CFS. The researchers used several Quality of Life indicators, including KPS, as well as a self-reported and physician completed instrument evaluating functionality, as endpoints assessing the clinical benefit of Ampligen.
Clinical endpoints included beneficial changes in KPS, cognitive deficit and vitality test scores. An activity monitor was also utilized in a subset of patients to help evaluate changes in physical activity during the study.
Ampligen dosing (200 to 400 mg twice weekly) and data collection intervals (every 8 weeks) were maintained during the study. Data from 41 severely debilitated CFS patients who have received at least 16 weeks of Ampligen treatment were available and included in the analyses.
Significant positive changes were reported by week 24. The drug treatment was generally well tolerated over the long-term and more than 80 percent of patients entered the second phase of the study after 24 weeks. HW