Table 5.
Cytokine Responses from Baseline in Patients with Chronic Fatigue Syndrome Enrolled in Two Clinical Trials of Rinitatolimod (Ampligen)
Cytokine | AMP-511 open-label study, 4 hours after rinitatolimod infusion |
AMP-516 placebo-controlled study, week 32 |
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---|---|---|---|---|---|---|
Rinitatolimod (n = 14) |
Rinitatolimod (n = 40) |
Placebo (n = 36) |
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Means ± SD | Median | Means ± SD | Median | Means ± SD | Median | |
IFN-γ (pg/mL) | 3.76 ± 26.14 | 0.00 | 1.00 ± 8.86 | 0.00 | 11.03 ± 63.44 | 0.00 |
TNF-α (pg/mL) | 1.21 ± 3.30 | 0.00 | 17.03 ± 94.73∗ | 1.00 | 1.56 ± 66.30 | 0.14 |
IL-12p70 (U/mL) | 1.22 ± 2.94 | 0.00 | 3.51 ± 22.28 | −0.33 | 0.39 ± 3.68 | −0.02 |
IL-10 (pg/mL) | 0.08 ± 0.39 | 0.00 | 4.04 ± 24.06 | 0.05 | −0.04 ± 0.63 | 0.00 |
The 400-mg infusions providing an approximately 6 mg/kg average dosing.
High means and SD values were secondary to one patient with a value of 500. Removal of this patient results in a mean value of 4.6.