YM BioSciences Cleared by FDA to Initiate Phase III Registrational Trial for Breast Cancer Drug

Pivotal trial to confirm previous positive phase III results for tesmilifene

06-Nov-2003

YM BioSciences Inc. , a cancer drug development company with an advanced-stage portfolio, announced that it has received written confirmation from the U.S. food and Drug Administration (FDA) that it may initiate a pivotal Phase III, or registrational trial, for its lead small-molecule anti-cancer therapeutic, tesmilifene.

"We are extremely pleased the FDA has cleared us to begin this trial and look forward to establishing tesmilifene's ability to enhance traditional chemotherapies and extend the survival time of women with metastatic breast cancer, as the drug has demonstrated in a previous Phase III trial," said David Allan, Chairman and CEO of YM BioSciences. "The incorporation of a sequential design into the protocol creates the possibility of significantly reduced trial time and costs compared with the usual, classic Phase III trial design in this indication."

The planned multi-center international trial will compare the overall survival times of advanced metastatic/recurrent breast cancer patients receiving tesmilifene in combination with epirubicin (an anthracycline) and cyclophosphamide versus epirubicin/cyclophosphamide alone. The primary endpoint of this pivotal trial is survival.

The FDA has approved the incorporation of a sequential design into the trial protocol, enabling an interim analysis to be made by an independent Data Monitoring Board after 50% of the planned number of events (deaths) have occurred, and if necessary every six months thereafter, without incurring any statistical penalty. If the required survival differential is achieved at the first interim analysis, recruitment for the trial could be completed in approximately two years.

This notification also follows the positive Special Protocol Assessment (SPA) by the FDA, approving the trial protocol design and endpoints.

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