Journal of IiME Volume 4 Issue 1 www.investinme.org Ampligen® in Severely Debilitated CFS Patients (continued) Figure 1: Use of Medications Known to Cause QT Prolongation: Individual Study Results from AMP-516 100 90 70 80 50 60 30 40 10 20 0 DE CREASED USE OF MEDICATIONS NO DECREASE D USE OF MEDICATIONS Poly I:Poly C12U Placebo P=0.048 (Chi-square test) 68 55 45 32 Decrease is defined as a reduction in the total number of days of exposure during the first 4 weeks of the study compared to the total number of days of exposure during the last 4 weeks of the study, only considering medications known to prolong QT. Methods: Elevated cytokine and interferon levels have been reported for a myriad of disorders, including CFS. Although the safety of poly(I)·poly(C12,U) has been demonstrated in over 30,000 patient treatment weeks and a wide dosing range without evidence of significant acute or cumulative toxicity, additional analyses of interferon and cytokine levels in patients’ sera were examined. A random sample of 48 patients (active and placebo) who completed the AMP-516 (Stage I ) study plus subjects who discontinued prematurely were selected for analyses of serum levels of interferons (α, β, and γ) and cytokines (TNF-α, IL-6, IL-10, and IL-12) at Baseline and Week 32 (or last observation for patients who discontinued prematurely). Invest in ME (Charity Nr. 1114035) Results: Elevated levels of interferons α, β, γ or cytokines IL6, IL-10, IL-12, or TNF- α, were seen at the baseline/pre-treatment visit for a subset of active and placebo patients, but no significant modulation of interferons or cytokines was seen. For each of the interferons and cytokines monitored, the data showed that the group changes from baseline levels in the poly(I)·poly(C12,U) treatment group over the treatment period up to Week 32 were indistinguishable and overlapped the observed levels in the placebo group. Two placebo treated subjects had the greatest increases in interferon levels and both completed the study. One poly(I)·poly(C12,U) treated subject had the greatest increases in the four cytokines, tolerated the treatment well, and completed the study. The data Page 34/56 PERCENTAGE OF PATIENTS
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