News

YM Bio gets thumbs up for tesmilifene trial

23 August 2006 09:03:00

YM BioSciences jumped today after the independent Data Safety Monitoring Board (DSMB) gave the green light for the continuation of trials of its breast cancer treatment tesmilifene.

The cancer product development firm said the DSMB for the pivotal phase III trial of tesmilifene in metastatic and recurrent breast cancer has concluded that the trial should continue as planned.

"We are encouraged by the DSMB's conclusion that our pivotal phase III trial should proceed," said chairman and chief executive David Allan.

"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."

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 Food and Drug Administration.

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