Oncothyreon announces initiation of Phase 3 trial of Stimuvax in breast cancer

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[{"type":"text","content":"\n\n\n\nSEATTLE, June 22 /CNW/ - Oncothyreon Inc. (Nasdaq: ONTY) (TSX:ONY) (the\n"Company") today announced that Merck KGaA of Darmstadt, Germany, has\ninitiated a global Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine,\nL-BLP25) in patients with hormone receptor-positive, locally advanced,\nrecurrent or metastatic breast cancer. Stimuvax is an investigational\ntherapeutic cancer vaccine being developed by Merck KGaA under a license\nagreement with Oncothyreon.\n\n\nThe Phase 3 trial, named STRIDE (STimulating immune Response In aDvanced\nbrEast cancer), is anticipated to enroll more than 900 patients at\napproximately 180 sites in over 30 countries - including North America,\nEurope, Asia and Australia. Patients with estrogen receptor-positive and/or\nprogesterone receptor-positive, non-resectable locally advanced, recurrent or\nmetastatic breast cancer receiving hormonal therapy will be randomized to\nreceive either Stimuvax or a placebo in a 2:1 ratio. The primary endpoint of\nSTRIDE is progression-free survival. Overall survival, quality of life, tumor\nresponse and safety will also be assessed in this study.\n\n\n"Advanced-stage breast cancer remains a devastating and challenging\ndisease and we urgently need new treatment options," said Dr. Larry Shulman,\nChief Medical Officer and Senior Vice President for Medical Affairs,\nDana-Farber Cancer Institute, Boston, Massachusetts, and Principal\nInvestigator of STRIDE. "If the results from the Phase 3 STRIDE study prove\npositive, this could make a difference for patients with hormone receptor\npositive metastatic breast cancer."\n\n\n"The initiation of the STRIDE study is an enormous step forward in\nclinical breast cancer research and represents our continued commitment to\ndeveloping Stimuvax within a robust clinical trial program across several\ncancer types. We are very excited that Stimuvax will now be tested in two\ndifferent cancer types in Phase III," said Dr. Oliver Kisker, Senior\nVice-President, Global Clinical Development Unit Oncology, Merck KGaA.\n\n\n"We are very pleased by the robust development program our partner, Merck\nKGaA, is conducting for Stimuvax," said Robert L. Kirkman, M.D., President and\nChief Executive Officer of Oncothyreon. "The addition of the Phase 3 STRIDE\ntrial in breast cancer t...

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