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YM BioSciences' safety board recommends tesmilifene pivotal trial continue
By Elaine Rigoli
Tampa, Fla., Aug. 22 - YM BioSciences, Inc. said Tuesday that the independent Data Safety Monitoring Board for the pivotal phase 3 trial of tesmilifene in metastatic and recurrent breast cancer has completed its second planned safety and efficacy analysis following 256 events and concluded that the trial should continue as planned.
"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," chairman and chief executive office David Allan said in a news release.
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.
Based in Mississauga, Ont., YM BioSciences develops oncology and acute-care products.
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