Table 4.
Summary of Immune Responders
| Treatment | IFNγ ELISpot response |
Naïve Treg fraction reduction |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| R1 |
R0 |
R0/R1 |
R1 |
R0 |
R0/R1 |
|||||||
| Total subjects tested | Responders (%) | Total subjects tested | Responders(%) | Total subjects tested | Responders (%) | Total subjects tested | Responders (%) | Total subjects tested | Responders (%) | Total subjects tested | Responders (%) | |
| GI-4000 | 15 | 6 (40.0)a | 52 | 16 (30.8) | 67 | 22 (32.8) | 9 | 3 (33.3) | 42 | 11 (26.2) | 51 | 14 (27.4)b |
| Placebo | 12 | 1 (8.3) | 50 | 22 (44.0) | 62 | 23 (37.1) | 7 | 1 (14.3) | 34 | 3 (8.8) | 41 | 4 (9.7) |
An increase or decrease in Tregs on treatment was defined as at least a twofold change in frequency from baseline.
a
p = 0.062, Pearson chi-square test, for GI-4000 versus placebo groups.
b
p = 0.033, Pearson chi-square test, for GI-4000 versus placebo groups.
IFNγ, interferon-γ.