Table 2.
DRF toxicology study of PVS-RIPO
| Animal | Dose (TCID50), volume, route | Euthanasia (day) | Biodistribution studies conducteda |
|---|---|---|---|
| A29114 | 0, 250 μl, intrathalamic | 3 | Complete biodistribution, stool shedding |
| A29098 | 0, 250 μl, intrathalamic | 21 | Complete biodistribution, stool shedding |
| A29135 | 1 × 10e7, 250 μl, intrathalamic | 3 | None |
| A29136 | 1 × 10e7, 250 μl, intrathalamic | 21 | Complete biodistribution, stool shedding |
| A29091 | 1 × 10e9, 250 μl, intrathalamic | 3 | None |
| A28814 | 1 × 10e9, 250 μl, intrathalamic | 21 | Complete biodistribution, stool shedding |
| A29159 | 5 × 10e9, 250 μl, intrathalamic | 3 | Complete biodistribution, stool shedding |
| A28838 | 5 × 10e9, 250 μl, intrathalamic | 21 | None |
| A29092 | 5 × 10e9, 250 μl, intrathalamic | 21 | Complete biodistribution, stool shedding |
a
Studies included biodistribution assays using the tissue panel shown in Table 4 (“complete biodistribution”) and TCID50/plaque assays for stool samples (“stool shedding”) obtained at study days 2, 4, 7, 14, and 21. The results of either assay were identical to the test results in the IND-directed study and are not discussed in detail.