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Review of Ampligen® clinical trials in Chronic Fatigue Syndrome

  [ 315 votes ]   [ 1 Comment ]
By W. Mitchell • www.ProHealth.com • January 17, 2007


Journal: Journal of Clinical Virology, Vol. 37, Supplement I, December 2006, pg. S113. [Sponsored by HHV-6 Foundation. E-Publication Jan 2007. Full text available for a fee at http://www.sciencedirect.com/science/journal/13866532 ] Author and affiliation: W. Mitchell. Chronic Fatigue Syndrome Clinical Consortium, Department of Pathology, Vanderbilt University School of Medicine, Nashville, TN, USA; Hemispherx Biopharma, Philadelphia, PA, USA. [E-mail: bill.mitchell@vanderbilt.edu ]

Objectives: Ampligen is a double-stranded (ds) RNA with well established broad antiviral and immunomodulatory properties that has been studied extensively in the treatment of Chronic Fatigue Syndrome (CFS). A total of five open-label and two double-blind, placebo-controlled trials have enrolled over 750 subjects. Primary endpoints have been achieved with statistical significance. No serious safety issues have resulted from the administration of ~75,000 doses IV (most commonly 400 mg) twice weekly for up to one year periods or greater. Animal toxicity studies support this observation in humans with primates demonstrating the greatest margin of safety.

In the recently completed Phase 3 trial, patients receiving Ampligen for 40 weeks improved exercise treadmill performance 14.8% compared to the placebo group (p = 0.025) and 12.9% by intent to treat analysis (p = 0.052), and this improvement represents twice the minimum considered medically significant (6.5%). The Ampligen cohort with Baseline exercise duration >9 min improved oxygen utilization compared to a decrease in the placebo group (p < 0.05). Increased oxygen utilization correlated significantly with improved treadmill exercise duration (p < 0.001). The KPS, as a function of general physical capacity, was similarly significantly correlated (p = 0.01) with the improvement in exercise tolerance of the Ampligen study arm.

Summary:
n Patients with CFS use large quantities of drugs to alleviate the symptoms associated with CFS. The concomitant use of drugs to treat symptoms of CFS was significantly less in the Ampligen arms of both the Phase 2 and Phase 3 controlled trials.
n Ampligen treatment in chronically debilitated CFS populations has demonstrated significant improvement in physical well being and quality of life that can be linked with dysregulation of gene expression associated with energy metabolism.
n The improvement in exercise duration is significantly correlated to improvement in oxygen utilization and physical performance.




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Article Comments Post a Comment

"Full text" of article for purchase is no more than what you see
Posted by: Wisty
Jun 4, 2009
Don't buy the "full text" of this article, which is available from the link near the top. For $31.50, you will get a pdf copy of the actual journal page. But the "full text" of the article -- which really is an abstract of a presentation made at a conference -- is exactly the text posted above. Rip off!
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