Table 1.
| a. Results of non-linear fitting in-vivo data
| |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HBV-DNA dynamics | HBsAg dynamics | ||||||||||||||||
| HepeX- B™ dose |
Patient number |
Baseline ALT |
Baseline HBV- DNA |
Half- life Decline |
Total Decline |
Clearance Acceleration |
Blocking Effectiveness |
HBeAg status |
Baseline HBsAg |
Half- life Decline |
Total Decline |
Clearance Acceleration |
Blocking Effectiveness |
||||
| (mg) | (U/L) | (log cp/ml) |
(hours) | (log cp/ml) |
low (c=5.5) |
high (c=0.69) |
low (c=0.69) |
high (c=5.5) |
(log ng/ml) |
(hours) | (log ng/ml) |
low (c=0.69) |
high (c=0.02) |
low (c=0.02) |
high (c=0.69) |
||
| 40 | 310 | 46 | 7.1 | 0.33 | 3.3 | 9.1 | 72.7 | 96.1% | 99.5% | NEG | 3.4 | 0.19 | 4.4 | 126 | 4800 | 80.9% | 99.50% |
| 40 | 311* | 102 | 7.6 | 0.53 | 2.9 | 5.7 | 45.5 | 94.0% | 99.3% | NEG | 3.7 | 0.13 | 4.6 | 179 | 6816 | 82.4% | 99.54% |
| 40 | 201 | 60 | 5.8 | 0.35 | 2.5 | 8.6 | 68.6 | 76.2% | 97.0% | NEG | 3.3 | 0.09 | 4.3 | 282 | 10729 | 46.2% | 98.6% |
| b. Analysis of in-vivo dynamics
| |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HBV-DNA dynamics | HBsAg Dynamics | ||||||||||||||||
| HepeX-B™ dose |
Patient number |
Baseline ALT |
Baseline HBV-DNA |
Half-life Decline |
Total Decline |
Acceleration of Clearance |
Effectiveness Blocking Release |
HBeAg status |
Baseline HBsAg |
Half-life Decline |
Total Decline |
Clearance Acceleration |
Blocking Effectiveness 3 |
||||
| (mg) | (U/L) | (log cp/ml) |
(hours) | (log cp/ml) |
low (c=5.5) |
high (c=0.69) |
low (c=0.69) |
high (c=5.5) |
(log ng/ml) |
(hours) | (log ng/ml) |
low (c=0.69) |
high (c=0.02) |
low (c=0.02) |
high (c=0.69) |
||
| 40 | 310 | 46 | 7.1 | 0.40 | 2.3 | 7.6 | 60.5 | 69.5% | 96.2% | NEG | 3.4 | 0.24 | 4.4 | 102 | 3859 | 82.8% | 99.55% |
| 40 | 311* | 102 | 7.6 | 0.56 | 1.8 | 5.3 | 42.5 | 34.4% | 91.8% | NEG | 3.7 | 0.23 | 4.6 | 106 | 4024 | 89.6% | 99.73% |
| 40 | 201 | 60 | 5.8 | 0.48 | 2.4 | 6.3 | 50.1 | 78.7% | 97.3% | NEG | 3.3 | 0.25 | 4.2 | 96 | 3644 | 76.3% | 99.38% |
|
| |||||||||||||||||
| 4 × 40 | 203 | 38 | 6.7 | 0.35 | 3.0 | 8.6 | 68.9 | 92.8% | 99.1% | POS | 3.2 | 0.29 | 4.1 | 83 | 3142 | 77.7% | 99.41% |
| 4 × 40 | 105 | 47 | 4.5 | 0.66 | 1.6 | 4.6 | 36.4 | 3.1% | 87.9% | NEG | 3.2 | 0.33 | 3.6 | 72 | 2736 | 33.3% | 98.2% |
| 4 × 40 | 202 | 19 | 8.8 | 13.9 | 0.1 | Non-Resp | Non-Resp | POS | 4.6 | 5.1 | 0.2 | Non-Resp | Non-Resp | ||||
|
| |||||||||||||||||
| 4 × 80 | 301 | 137 | 6.5 | 0.31 | 3.3 | 9.6 | 76.5 | 96.2% | 99.5% | NEG | 3.7 | 0.29 | 4.1 | 82 | 3108 | 75.5% | 99.36% |
| 4 × 80 | 106 | 87 | 7.7 | 0.34 | 3.1 | 8.9 | 71.3 | 94.1% | 99.3% | NEG | 2.9 | 0.33 | 3.6 | 72 | 2746 | 35.0% | 98.3% |
| 4 × 80 | 311* | 120 | 5.5 | 0.38 | 2.7 | 7.8 | 62.7 | 87.8% | 98.5% | NEG | 3.4 | 0.28 | 4.2 | 84 | 3206 | 81.2% | 99.51% |
|
| |||||||||||||||||
| Mean | 6.4 | 0.44 | 2.5 | 7.3 | 58.6 | 69.6% | 96.2% | 3.5 | 0.28 | 4.1 | 87 | 3308 | 68.9% | 99.18% | |||
*
Patient participated in both phase 1A and phase 1B studies