YM BioSciences breast cancer study to continue

The 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 FDA.

It is being conducted according to a sequential design that permits a number of analyses and will continue until one of two specific statistical conditions is satisfied.

At each analysis, the hazard ratio between the tesmilifene-containing treatment arm and the control arm is calculated and then reviewed by the data safety monitoring board (DSMB), and the trial may be concluded if either the tesmilifene-containing treatment arm is superior to the control by a specified margin or it is determined that such evidence is not going to be found.

If the evidence is insufficient for either conclusion to be drawn, then the study continues until the next analysis. The third analysis is expected to occur in Q3/Q4 2006, although, based on the data available to date, it is not possible to determine exactly when it will occur, nor do the available data permit an accurate prediction of the outcome of the trial.

“We are encouraged by the DSMB’s conclusion that our pivotal phase III trial should proceed,” said David Allan, chairman and CEO of YM BioSciences. “Based on the study design, we believe the trial continues to have the prospect to yield a positive outcome. Further, this analysis also confirms that tesmilifene continues to demonstrate a good safety profile.”