Table 6.

SET-M33-related changes in beagle dogs dosed with the peptide at 0 (vehicle = 0.9% saline solution), 0.5, 1.5 and 4.0 mg/kg/day for 28 days and after 4-week recovery.

			Male				Female
			0 mg/kg/day	0.5 mg/kg/day	1.5 mg/kg/day	4.0 mg/kg/day	0 mg/kg/day	0.5 mg/kg/day	1.5 mg/kg/day	4.0 mg/kg/day
Kidney weight changes (% difference relative to controls)
Kidney	Absolute weight (%)			–	–	8.63		–	–	15.16
	vs. body weight (%)			–	–	11.47		–	–	9.56
	vs. brain weight (%)			–	–	9.80		–	–	13.59
SET-M33-related findings in the kidney after 28-days dosing and after the 4-week recovery period
4-week dosing	Degeneration/regeneration, tubules	Minimal	0	2	3	0	0	0	0	2
	Infiltrate, interstitium	Minimal	0	0	1	0	0	0	0	1
4-week recovery period	Regeneration, tubules	Minimal	0	0	0	0	0	0	0	1
SET-M33-related findings at infusion site after 28-days dosing and after the 4-week recovery period (combined incidence from all four sites)
4-week dosing	Thrombus, blood vessels	Minimal	0	1	0	0	0	0	0	0
		Slight	0	0	0	2	0	1	0	0
		Moderate	0	0	0	5	0	0	1	5
		High	0	0	0	1	0	0	0	0
		Total	0	1	0	8	0	1	1	5
	Inflammation, vascular/perivascular	Minimal	0	2	3	0	1	0	1	1
		Slight	0	1	2	0	0	0	1	4
		Moderate	0	0	0	0	0	0	0	1
		Total	0	3	5	0	1	0	2	6
	Hypertrophy/hyperplasia, tunica intima	Minimal	0	0	0	0	1	0	0	0
		Slight	0	1	1	0	0	0	0	0
		Total	0	1	1	0	1	0	0	0
	Hypertrophy/hyperplasia, tunica media	Minimal	0	0	0	1	0	0	0	0
		Slight	0	2	0	2	0	0	1	0
		Total	0	2	0	3	0	0	1	0
	Haemorrhage, vascular/perivascular	Minimal	0	1	1	0	2	1	3	2
		Slight	0	1	0	1	2	1	0	3
		Moderate	0	0	0	0	0	0	1	0
		Total	0	2	1	1	4	2	4	5
4-week recovery period	Thrombus, blood vessels	Slight	0	0	0	0	0	0	0	1
		Total	0	0	0	0	0	0	0	1
	Hypertrophy/hyperplasia, tunica media	Slight	0	0	0	1	0	0	0	0
		Total	0	0	0	1	0	0	0	0

For kidney weight changes statistical analysis was not performed due to the small number of animals.