YM BioSciences prepares for interim analysis of data from phase 3 trial of tesmilifene in breast cancer

By Lisa Kerner

Charlotte, N.C., June 7 - YM BioSciences Inc. said the 192 events required for the first interim analysis in its pivotal phase 3 trial of small molecule drug tesmilifene in metastatic and recurrent breast cancer have occurred.

The Data Safety Monitoring Board is expected to complete a formal statistical analysis within the next four weeks, according to a company news release.

Although the board requires clarification on a small number of patients, it had no safety concerns.

Overall survival is the primary endpoint of the study, which is designed to detect a 33% improvement in overall survival based on 384 events, the company said.

Located in Mississauga, Ont., YM BioSciences develops oncology and acute care products.

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