YM Biosciences, sanofi-aventis collaborate on breast cancer study of tesmilifene and docetaxel

By E. Janene Geiss

Philadelphia, Jan. 10 - YM BioSciences Inc. announced Tuesday that it will collaborate with sanofi-aventis to investigate the effect of combining tesmilifene and docetaxel to treat women with rapidly progressing metastatic breast cancer.

The initial study will be conducted in Europe and at U.S. Oncology Inc. sites in the United States, according to a company news release.

Tesmilifene is a small molecule that has been shown to significantly improve the effectiveness of commonly used cancer chemotherapies prolonging survival when compared to chemotherapy alone, officials said. Docetaxel, made by sanofi-aventis, is a second-generation taxane that is commonly used in patients with recurrent or metastatic breast cancer.

The purpose of the study is to determine if the addition of tesmilifene to docetaxel has the potential to improve clinical response without increasing toxicity in patients, officials said.

Prior positive phase 3 clinical data on the combination of tesmilifene and chemotherapy have been reported to significantly increase survival in women with metastatic and recurrent breast cancer.

And officials said the effects of docetaxel in multiple drug-resistant cancer cells were enhanced when these cells were exposed to tesmilifene in preclinical studies.

Consequently, the approach of combining docetaxel with tesmilifene is now being studied as a potential means of enhancing the survival of these late-stage cancer patients, officials said.

The initial collaborative study will enroll up to 39 women with rapidly progressing metastatic breast cancer in which patients with recurrence of this disease within 24 months of the initial diagnosis of breast cancer will be included, officials said.

Patients will be administered docetaxel every 21 days and tesmilifene will be administered by a single infusion at the start of each docetaxel cycle. Treatment will continue for up to 29 weeks unless there is evidence of unacceptable toxicity or disease progression, officials said.

U.S. Oncology Inc. is a health care services network in the United States dedicated exclusively to cancer treatment and research.

YM BioSciences is a Mississauga, Ont., cancer product development company. In addition to tesmilifene, YM is developing nimotuzumab, an anti-EGFr humanized monoclonal antibody, in a number of indications.

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