YM Biosciences' phase 3 trial of tesmilifene for breast cancer passes first interim analysis

New York, June 26 - YM BioSciences Inc. said the data safety monitoring board for its phase 3 trial of tesmilifene in metastatic and recurrent breast cancer approved continuation of the study as planned after the first interim safety and efficacy analysis.

The interim analysis was based on 215 deaths which occurred as of June 8. The second of three interim analyses is planned after 256 deaths and is expected in the third quarter.

"The next interim analysis for our trial is expected to occur shortly and, as per the statistical plan and design of the trial, at each subsequent analysis the level of survival improvement tesmilifene must demonstrate is lowered. Thus the probability of success improves with each interim analysis," said David Allan, chairman and chief executive officer of YM BioSciences, in a news release.

"We are pleased that tesmilifene continues to display a good safety profile and remain optimistic based on the efficacy results tesmilifene produced in its first phase 3 trial."

The trial is comparing the overall survival of patients treated with tesmilifene combined with epirubicin/cyclophosphamide to epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic and recurrent breast cancer. Enrollment of 723 patients was completed in September 2005.

The trial will be considered positive if the tesmilifene arm is superior to the control arm with an improvement in overall survival ranging from 50% initially (first interim analysis) to 33% at the final analysis.

YM is a Mississauga, Ont., oncology and acute care company.

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