Table 3.
IND-directed toxicology study of PVS-RIPO
| Animal | Group: dose (TCID50), vol, route | Euthanasia (day) | Study resulta |
|---|---|---|---|
| A08404 | 1: 0, 250 μl, intrathalamic | 3 | Complete biodistribution |
| A10102 | 1: 0, 250 μl, intrathalamic | 3 | None |
| A09134 | 1: 0, 250 μl, intrathalamic | 10 | Complete biodistribution |
| A07639 | 1: 0, 250 μl, intrathalamic | 10 | None |
| A06682 | 1: 0, 250 μl, intrathalamic | 56 | Select biodistribution, neutralizing antibodies |
| A06953 | 1: 0, 250 μl, intrathalamic | 56 | Neutralizing antibodies |
| A09731 | 2: 5 × 10e7, 250 μl, intrathalamic | 3 | None |
| A10091 | 2: 5 × 10e7, 250 μl, intrathalamic | 3 | None |
| A10171 | 2: 5 × 10e7, 250 μl, intrathalamic | 3 | None |
| A10174 | 2: 5 × 10e7, 250 μl, intrathalamic | 3 | None |
| A09131 | 2: 5 × 10e7, 250 μl, intrathalamic | 10 | None |
| A09160 | 2: 5 × 10e7, 250 μl, intrathalamic | 10 | None |
| A09723 | 2: 5 × 10e7, 250 μl, intrathalamic | 10 | None |
| A09732 | 2: 5 × 10e7, 250 μl, intrathalamic | 10 | None |
| A08411 | 2: 5 × 10e7, 250 μl, intrathalamic | 56 | None |
| A09252 | 2: 5 × 10e7, 250 μl, intrathalamic | 56 | None |
| A10093 | 2: 5 × 10e7, 250 μl, intrathalamic | 56 | None |
| A10095 | 2: 5 × 10e7, 250 μl, intrathalamic | 56 | None |
| A08132 | 3: 1 × 10e9, 250 μl, intrathalamic | 3 | Complete biodistribution |
| A08760 | 3: 1 × 10e9, 250 μl, intrathalamic | 3 | Complete biodistribution |
| A09763 | 3: 1 × 10e9, 250 μl, intrathalamic | 3 | Complete biodistribution |
| A09750 | 3: 1 × 10e9, 250 μl, intrathalamic | 3 | CNS biodistribution |
| 30027 | 3: 1 × 10e9, 250 μl, intrathalamic | 10 | Complete biodistribution |
| A09158 | 3: 1 × 10e9, 250 μl, intrathalamic | 10 | CNS biodistribution |
| A10107 | 3: 1 × 10e9, 250 μl, intrathalamic | 10 | CNS biodistribution |
| A10129 | 3: 1 × 10e9, 250 μl, intrathalamic | 10 | CNS biodistribution |
| A09163 | 3: 1 × 10e9, 250 μl, intrathalamic | 56 | Select biodistribution, shedding, neutralizing antibodies |
| A08813 | 3: 1 × 10e9, 250 μl, intrathalamic | 56 | Select biodistribution, shedding, neutralizing antibodies |
| A09165 | 3: 1 × 10e9, 250 μl, intrathalamic | 56 | Shedding, neutralizing antibodies |
| A10103 | 3: 1 × 10e9, 250 μl, intrathalamic | 56 | Shedding, neutralizing antibodies |
a
For tissue inclusion with the biodistribution studies (complete, select, and CNS), see Table 4. Shedding studies included serum (viremia), saliva, urine, and stool samples.