Table 4: Pilot toxicokinetic dose range-finding study for IT-147 formulation. IT-147 was administered at 20, 30, and 40 mg/kg epothilone D equivalent compared to free drug at 20 mg/kg. Limited pharmacokinetic sampling was used to determine , AUC, clearance, and half-life data for each animal up to 6 hours after test article administration.

Test articleDose (mg/kg)Animals per group (µg/mL)  (hµg/mL)Clearance (mL/h/kg)Half-life (h)Dose limiting Toxicities

Epo D20632.28.32414.70.3>10% w.l. lethargy impaired gait orbital-bleeding
IT-14720459.153.5373.74.3None
IT-14730485.482.9361.85.110% w.l. slight-lethargy
IT-147404107.6110.8361.04.4>10% w.l. lethargy impaired gait orbital-bleeding