Review of Ampligen® clinical trials in Chronic Fatigue Syndrome

仁者深潜

The journalist from thestreet.com recently pointed out that p>0.05 is considered not medically significant. But the truth just tells the otherwise. see the bold part of the article.
secondly, ampligen has been waiting for the moment over 40 years, it means that a huge load of trials and experiments have been done to prove the drug's potency or efficacy before filing NDA.
also, the international recognition of ampligen's unique treatment on virus related diseases such as HIV, SWINE FLU, Hepatitis B, C.... particularly recently from Japan government admit on ampligen's effecacy on flu  virus is a big plus added to its huge potential market in the future.
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Review of Ampligen® clinical trials in Chronic Fatigue Syndrome
by W. Mitchell
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.