Breast Cancer

FDA gives approval for phase III registrational trial for breast cancer drug

Published in Women's Health Weekly, December 4th, 2003

YM BioSciences Inc. (YMBA) 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 chief executive officer of YM BioSciences.

"The incorporation of a sequential design into...

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Source: Women's Health Weekly (2003-12-04)

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