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YM BioSciences, Inc. Ordinary S Message Board

  • breccia_zone breccia_zone Jan 4, 2006 6:04 PM Flag

    tesmilifene phase 3??

    when are results expected? thanks

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    • You were correct. I did not know as much as I should have about previous study results. The website is inadeqate in terms of supplying such information. Thank you for filling me in. I did a search and confirmed the results you supplied. I feel better about ymi.

    • Tesmilifene completed enrollment of its final 700th patient right on schedule at the end of September 2005 (in 103 hospitals and 17 countries worldwide). The Phase III trial is a pivotal trial of Tesmilifene with epirubicin and cyclophosphamide in Metastatic Breast Cancer. The target patient population, defined by the registration trial, are patients with rapidly progressing disease, the most responsive category (+143% survival comparison) in the first Phase III trial (e.g., an analysis of overall survival in a subgroup of patients enrolled in a previous Phase III trial (MA.19) was published in the Proceedings of ASCO 2005 and demonstrated that tesmilifene extended median survival in a similar patient population from 12.2 to 29.2 months (143%:p=0.0016) when added to doxorubicin versus doxorubicin alone).

      In Q2 2003, the FDA accepted a Sequential Analysis for the trial that permits early conclusion of the trial following 192 �events,� provided certain criteria are met. If the survival in the control arm mirrors the results from the similar population in MA.19 (the first Phase III trial) and the outcomes are positive, YMI anticipates the current trial could be completed by mid-2006, and product launch and commercialization possible by early 2007.

 

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