Table 4.
The summary of the final TOX-2014-001 GLP preclinical D2C7-IT toxicity trial
| Group | Cohort | D2C7-IT Total Dose (µg) in 3 days |
No. of Animals |
No. of rats showing abnormal clinical signs |
No. of unscheduled mortality |
Histopathology Report | |||
|---|---|---|---|---|---|---|---|---|---|
| ECM | Edema | Demyelination | Others | ||||||
| Control* | Acute | 0 | 10 (5 males, 5 females) | 0 | 0 | 6 | 0 | 0 | N/A |
| Chronic | 10 (5 males, 5 females) | 0 | 0 | 4 | 0 | 0 | 1 gliosis | ||
| D2C7-IT low dose |
Acute | 0.05 | 10 (5 males, 5 females) | 0 | 0 | 5 | 0 | 0 | 1 possible infarct, 1 mild hydrocephalus, 1 focal hemorrhage |
| Chronic | 10 (5 males, 5 females) | 0 | 0 | 2 | 0 | 0 | N/A | ||
| D2C7-IT median dose |
Acute | 0.1 | 10 (5 males, 5 females) | 0 | 0 | 4 | 0 | 0 | 1 possible abscess |
| Chronic | 10 (5 males, 5 females) | 0 | 0 | 3 | 0 | 0 | 1 mild hydrocephalus | ||
| D2C7-IT high dose 1 |
Chronic | 0.35 | 10 (5 males, 5 females) | 4 | 4 (2 males, 2 females) | 7 | 2 | 4 | 2 abscess, 1 mild hydrocephalus, 1 gliosis |
| D2C7-IT high dose 2 |
Acute | 0.4 | 10 (5 males, 5 females) | 5 | 5 (3 males, 2 females) | 9 | 8 | 2 | 3 mild hydrocephalus, 1 hemorrhage |
*
Control formulation: Potassium phosphates in saline, 2% RSA, 2 µCi 124I-HSA, 1 mM Gd-DTPA