Table 2.

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

GroupTreatment regimen
Median
T-C%TGDStatistical significance*
MTV
Statistical significance
Regressions
Mean BW nadirTR deaths
Agentmg/kgScheduleTTEvs G1vs G5vs G6Day 33vs G1vs G5vs G6PRCRTFS
1Vehicleqwk ×333.61018 ± 1980000
2Tubulysin0.1qwk ×334.50.93nenene651 ± 59.5nenene000−26.8% Day 265
3Paclitaxel30qod ×576.342.7127ns11 ± 8.1ns§191−10.2% Day 120
4Vinblastine4qwk ×345.111.534§ns633 ± 357000−3.6% Day 40
5CDP-TubA3qwk ×373.539.911988.1 ± 85.8631−2.2% Day 40
6CDP-TubA3qd ×156.923.369350 ± 193000−2.9% Day 40
  • 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.