Overview of all Studies with Ampligen in CFS
K, De Meirleir [1], P. De Becker [1], I. Campine [1], E. Van Steenberge [1], A. Leys [1], D. Strayer [2], W. Carter [2]
1
Human Physiology and Medicine
V.U.B
Brussels
Belgium
2 Hemispherix Biopharma
Philadelphia
PA
USA
To review results from three separate clinical studies of AmpligenŽ in
Chronic Fatigue Syndrome.
Chronic Fatigue Syndrome (CFS) is a symptom complex characterised by both
chronic physical debilitation as well as impairments in concentration
and short term memory, Although the etiology of CFS remains elusive, abnormalities
in immune function and viral reactivation have been reported. We have
investigated the role of a double-stranded RNA, AmpligenŽ, which acts
as a biological response modifier with both antiviral and immunomodulatory
activity. 130 individuals meeting the original (1988) CDC case definition
for CFS hnie been studied in two open-label (Studies A and B) and one
placebo-controlled study of AmpligenŽ (Study C). The results of these
three clinical studies, which utilised similar ArnpligenŽ dosage levels
and duration of therapy, were reviewed.
Following 24 weeks of therapy the most consistent finding among these
trials was significant physical improvement as measured by Karnofsky Performance
Score and exercise performance (treadmill or bicycle). In addition, significant
cognitive improvements were documented using the cognitive subscale of
the SCL90-R or neuropsychological function tests. Moreover, the twice
weekly ArnpligenŽ treatments (200-400 mg) were generally well tolerated
without evidence of cumulative toxicities. No clinically significant abnormalities
were seen in blood chemistry, coagulation or hematological parameters.
In conclusion, a review of results using AmpligenŽ in CFS has shown evidence
of clinical activity with increases in physical performance and perceived
cognition in three separate clinical trials without evidence of significant
toxicities.
Latest News | Research | Information | Advocacy | Conference | Guidelines
