1998 Clinical and Scientific Meeting

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

Overview of all Studies with Ampligen in CFS

Objective
To review results from three separate clinical studies of Ampligen® in Chronic Fatigue Syndrome.

Methods
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, Ampligen®, 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 Ampligen® (Study C). The results of these three clinical studies, which utilised similar Arnpligen® dosage levels and duration of therapy, were reviewed.

Results
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 Arnpligen® 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.

Summary
In conclusion, a review of results using Ampligen® 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.

 

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Phone/Fax +61 2 9958 6285

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