Table 5.
Formation of anti-Ab-01 antibodies (log Titer) after a single 10 mg/kg IV dosage of Ab-01 to male cynomolgus monkeys
| TIME (DAYS) |
ANIMAL 1 | ANIMAL 2 | ANIMAL 3 |
|---|---|---|---|
| Pre-dose | Negative | Negative | Negative |
| 15 | Negative | Negative | Negative |
| 22 | Negative | Negative | Negative |
| 36 | Negative | 2.13 | Negative |
| 50 | Negative | 3.43 | Negative |
| 71 | ND | ND | Negative |
| 92 | Negative | ND | 2.27 |
| 106 | ND | ND | 2.79 |
| 113 | Negative | ND | ND |
| 134 | 1.86 | ND | ND |
| 148 | 2.4 | ND | ND |
"ND" = Not determined
Formation of anti-Ab-01 antibodies (neutralizing and non-neutralizing) was assessed using an electrochemiluminescent paramagnetic bead assay, in which serum samples from Ab-01-dosed monkeys were tested for binding to biotinylated- Ab-01 and ruthenylated- Ab-01. Negative samples had no binding at the minimum required dilution of 1:25 and had a log titer < 1.40.