Canadian drug developer YM BioSciences says that the independent data safety monitoring board reviewing a Phase III trial of its drug tesmilifene in breast cancer has recommended that it continue as planned. The IDSMB reached the decision following its second planned safety and efficacy analysis.
The study, which completed enrollment of 723 patients in September 2005, compares the survival time achieved by metastatic and/or recurrent breast cancer patients treated with combined tesmilifene and epirubicin/cyclophosphamide with those who receive only epirubicin/cyclophosphamide. The firm added that the drug is also under assessment in a separate study in combination with French drug major Sanofi-Aventis' Taxotere (docetaxel).
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