YMI should also be starting 2 phase 3 trials very soon.
Tesmilifene has been administered to approximately 600 cancer patients to date and has been shown to be well tolerated. In a Phase III trial in metastatic breast cancer, 305 patients were enrolled by the National Cancer Institute of Canada. The final results of the trial, published in the Journal of Clinical Oncology on January 15, 2004, demonstrated an unrivaled 50% increase in median overall survival time. For advanced hormone-refractory prostate cancer, recruitment for a single-armed 28-patient Phase II trial has been completed. Preliminary results presented at ASCO indicate a high response rate (70%).
The pivotal Phase III trial was initiated in March 2004, enrolling 700 patients at 86 sites across 13 countries. The outcome of the trial will be reviewed in light of the Special Protocol Assessment received by YM from the FDA. Because of a subsequent agreement with the FDA to appy a Sequential Analysis to the trial that permits stopping the trial following 192 "events" provided certain criteria are met, YM anticipates that the trial might be completed as early as mid-2006.