YM BioSciences starts treatment in phase 2 trial of tesmilifene with Taxotere

New York, June 5 - YM BioSciences Inc. said it has begun treating patients in its phase 2 trial combining tesmilifene with Taxotere (docetaxel).

The trial is being conducted in collaboration with Sanofi-Aventis and will investigate the effect of this drug combination in women with rapidly progressing metastatic breast cancer.

Researchers aim to determine whether the addition of tesmilifene to docetaxel has the potential to improve clinical response without increasing toxicity in patients.

The primary endpoint of the trial is pharmacokinetic, assessing the effect of addition of tesmilifene on the plasma concentration of docetaxel.

YM anticipates enrollment will be completed in the fourth quarter and that pharmacokinetic data will be available in the first quarter of 2007.

The secondary endpoints are overall survival and progression-free survival. Survival data from this trial will be compared to historical survival data for Taxotere alone.

The single-arm study is expected to enroll up to 39 women who are diagnosed with metastatic breast cancer or had their cancer recur within 24 months of their initial breast cancer diagnosis. Patients will be administered docetaxel every 21 days and tesmilifene will be administered by a single infusion at the start of each docetaxel cycle. Following a five-patient dose escalation component, patients will be treated for up to 29 weeks unless there is evidence of unacceptable toxicity or disease progression.

The study is being conducted in Europe and the United States.

YM is a Mississauga, Ont., cancer product development company.

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