SEATTLE, June 22 /CNW/ - Oncothyreon Inc. (Nasdaq: ONTY) (TSX:ONY) (the "Company") today announced that Merck KGaA of Darmstadt, Germany, has initiated a global Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine, L-BLP25) in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Stimuvax is an investigational therapeutic cancer vaccine being developed by Merck KGaA under a license agreement with Oncothyreon.

The Phase 3 trial, named STRIDE (STimulating immune Response In aDvanced brEast cancer), is anticipated to enroll more than 900 patients at approximately 180 sites in over 30 countries - including North America, Europe, Asia and Australia. Patients with estrogen receptor-positive and/or progesterone receptor-positive, non-resectable locally advanced, recurrent or metastatic breast cancer receiving hormonal therapy will be randomized to receive either Stimuvax or a placebo in a 2:1 ratio. The primary endpoint of STRIDE is progression-free survival. Overall survival, quality of life, tumor response and safety will also be assessed in this study.

"Advanced-stage breast cancer remains a devastating and challenging disease and we urgently need new treatment options," said Dr. Larry Shulman, Chief Medical Officer and Senior Vice President for Medical Affairs, Dana-Farber Cancer Institute, Boston, Massachusetts, and Principal Investigator of STRIDE. "If the results from the Phase 3 STRIDE study prove positive, this could make a difference for patients with hormone receptor positive metastatic breast cancer."

"The initiation of the STRIDE study is an enormous step forward in clinical breast cancer research and represents our continued commitment to developing Stimuvax within a robust clinical trial program across several cancer types. We are very excited that Stimuvax will now be tested in two different cancer types in Phase III," said Dr. Oliver Kisker, Senior Vice-President, Global Clinical Development Unit Oncology, Merck KGaA.

"We are very pleased by the robust development program our partner, Merck KGaA, is conducting for Stimuvax," said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. "The addition of the Phase 3 STRIDE trial in breast cancer to the Phase 3 START trial in non-small cell lung cancer (NSCLC) is evidence of their strong commitment to this innovative product candidate."

About Stimuvax

Stimuvax is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a glycoprotein antigen widely expressed on common cancers. MUC1 is over-expressed on many cancers such as lung cancer, breast cancer, prostate cancer and colorectal cancer.