YM BioSciences has announced that treatment has been started in its Phase II trial combining tesmilifene with Taxotere (docetaxel). The trial is being conducted in collaboration with sanofi-aventis and will investigate the effect of this drug combination in women with rapidly progressing metastatic breast cancer.
The purpose of the study is to determine if the addition of tesmilifene to docetaxel has the potential to improve clinical response without increasing toxicity in patients. The primary endpoint of the trial is pharmacokinetic; assessing the effect of addition of tesmilifene on the plasma concentration of docetaxel. The company anticipates enrolment will be completed in calendar Q4, 2006 and that pharmacokinetic data will be available in calendar Q1, 2007. The secondary endpoints are overall survival and progression-free survival. Survival data from this trial will be compared to historical survival data for Taxotere alone.