by Sasha Nimmo
Drug company research team identifies which CFS patients may respond best to Ampligen.
Hemispherx Biopharma has identified new criteria to see which CFS patients may get significant clinical benefit from Ampligen (rintatolimod). Patients who are able to complete more than 9 minutes of exercise (modified Bruce protocol exercise tolerance test) are likely to benefit from Ampligen.
Data from a previous Phase III clinical trial of Ampligen were analysed to determine whether baseline exercise tolerance could be used to predict responses to Ampligen vs. placebo in CFS patients. A modified treadmill test was used because of the severe physical exercise intolerance of CFS patients. The paper uses both 1988 Holmes criteria and 1994 Fukuda criteria to define CFS patients.
For patients with baseline exercise tolerance of more than 9 minutes, 33% of patients on Ampligen improved exercise tolerance duration by 25% or more (vs. 12% of patients on placebo), while 23% of Ampligen-treated patients improved by 50% or more (compared to 4.5% placebo patients).
There was also a group of patients identified who, although termed ‘non responders’, had their deterioration slowed by taking Ampligen.
What prompted this research?
This study was prompted by the Phase III clinical trial, where patients were given Ampligen twice weekly for 40 weeks compared to placebo. Some patients dramatically responded while others did not. Their hypothesis was that baseline exercise tolerance could be used to predict responses to rintatolimod. This report identifies three classes of patients. The first is defined by marked improvement in exercise tolerance and quality of life. The second class was not significantly responsive. The third class, although deteriorating on rintatolimod, do so at a reduced rate compared to controls.
Full paper: Published in the Journal of Drug Research and Development, the paper is Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME): Characteristics of Responders to Rintatolimod.