Stabilized Polymer Micelles for the Development of IT-147, an Epothilone D Drug-Loaded Formulation

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 article	Dose (mg/kg)	Animals per group	(µg/mL)	(hµg/mL)	Clearance (mL/h/kg)	Half-life (h)	Dose limiting Toxicities
Epo D	20	6	32.2	8.3	2414.7	0.3	>10% w.l. lethargy impaired gait orbital-bleeding
IT-147	20	4	59.1	53.5	373.7	4.3	None
IT-147	30	4	85.4	82.9	361.8	5.1	10% w.l. slight-lethargy
IT-147	40	4	107.6	110.8	361.0	4.4	>10% w.l. lethargy impaired gait orbital-bleeding