– in the COLO 205 human colorectal adenocarcinoma nude mouse xenograft model
NTS Research contracted Charles River Discovery Services North Carolina (CR Discovery Services) to evaluate SAC Calcium on two dosing schedules for tumor growth inhibition (TGI) in the COLO 205 human colorectal adenocarcinoma nude mouse xenograft model. In the Colo205-e347 study, SAC Calcium was administered orally (p.o.) at 0.83 mg/kg to two groups. One received dosing twice daily with 1 dose on the first day (bid to end, first day 1 dose) and the other received dosing three times daily with 2 doses on the first day (tid to end, first day 2 doses). Treatments began on Day 1 in mice with established subcutaneous COLO 205 tumors. The study included a vehicle control group, dosed tid to end, first day 2 doses. The study endpoint was a mean tumor volume of 2000 mm³ in the control group or 28 days, whichever came first. The study ended on Day 28. Treatment response was determined from an analysis of percent tumor growth inhibition (%TGI), defined as the percent difference between median tumor volumes (MTVs) of treated and control groups, with differences between groups deemed statistically significant at P≤ 0.05 using the Mann-Whitney U test. Tumor regressions, mean tumor growth, and treatment tolerability also were considered. In Summary, the median tumor volume on Day 28 for the control Group 1 was 936 mm³. Treatment of animals with SAC Calcium at 0.83 mg/kg, administered bid to end, first day 1 dose and tid to end, first day 2 doses was associated with TGI of 0% and 8%, respectively. Treatments administered in the study were acceptably tolerated based on group mean BW measurement and clinical observations.