Table 2.

Antitumor activity of CDP-TubA in the HT29 human colorectal carcinoma xenograft model in nude mice

Group	Treatment regimen					Median	T-C	%TGD	Statistical significance*					MTV	Statistical significance^†					Regressions					Mean BW nadir	TR deaths
Group		Agent	mg/kg	Schedule	TTE		T-C	%TGD		vs G1	vs G5	vs G6	Day 33	vs G1	vs G5	vs G6	PR	CR	TFS						Mean BW nadir	TR deaths
1	Vehicle	−	qwk ×3	33.6	—	—	—	^‡	^‡	1018 ± 198	—	^‡	^‡	0	0	0	—	0
2	Tubulysin	0.1	qwk ×3	34.5	0.9	3	ne	ne	ne	651 ± 59.5	ne	ne	ne	0	0	0	−26.8% Day 26	5
3	Paclitaxel	30	qod ×5	76.3	42.7	127	^‡	ns	^‡	11 ± 8.1	^‡	ns	^§	1	9	1	−10.2% Day 12	0
4	Vinblastine	4	qwk ×3	45.1	11.5	34	^§	^‡	ns	633 ± 357	^‡	^‡	^∥	0	0	0	−3.6% Day 4	0
5	CDP-TubA	3	qwk ×3	73.5	39.9	119	^‡	—	^‡	88.1 ± 85.8	^‡	—	^∥	6	3	1	−2.2% Day 4	0
6	CDP-TubA	3	qd ×1	56.9	23.3	69	^‡	^‡	—	350 ± 193	^‡	^∥	—	0	0	0	−2.9% Day 4	0

NOTE: Potency was evaluated using log-rank testing on the time it took for individual tumors to reach a predetermined endpoint (TTE) of 1,000 mm³ and by comparing the mean tumor volume (MTV) for different treatment groups when tumors of vehicle-treated animals reached 1,000 mm³ (day 33). Ten animals per group were treated. CDP-TubA (batch #1) doses are in tubulysin equivalents.
Vehicle, 10% DMSO: 1% Tween 80 in saline.
T-C, difference between median TTE (d) of treated versus control group; %TGD, [(T-C)/C] × 100.
MTV, mean tumor volume ± SD (mm³) on the day the vehicle control group mean tumor volume reached the predetermined endpoint of 1,000 mm³.
Mean BW nadir, lowest group mean body weight, as % change from Day 1; —, no decrease in mean body weight was observed.
Abbreviations: PR, partial regressions; CR, total number complete regressions; TFS, tumor-free survivors, i.e., CRs at end of study; TR, treatment-related; ne, not evaluable; ns, not significant.
↵* Statistical significance, Log-rank test.
↵† Statistical significance, ANOVA w. Tukey's post test.
↵‡ P < 0.001.
↵§ P < 0.01.
↵∥ P < 0.05.