YM's Ph III tesmilifene trial to continue

YM BioSciences, a US oncology specialist, says that an independent Data Safety Monitoring Board has notified it that 320 events have occurred so far in the pivotal Phase III trial of its drug tesmilifene, in patients with metastatic or recurrent breast cancer, which is the number required for the third interim analysis to begin.

Since the last data sweep was completed in November 2006, the DSMB advised the company to conduct a further collection to bring the survival data current prior to performing the third interim analysis. This is ongoing and YM expects it to be completed and to have a formal recommendation from the DSMB in February.

The pivotal Phase III trial compares the survival of patients treated with tesmilifene combined with epirubicin/cyclophosphamide to epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic and/or recurrent breast cancer. The trial, which completed enrollment of 723 patients in September 2005, is the subject of a Special Protocol Assessment and a Fast Track designation for advanced breast cancer by the US Food and Drug Administration.