Oncothyreon (ONTY) Announces Initiation of Phase 3 Trial of Stimuvax(R)
Oncothyreon Inc. (Nasdaq: ONTY) 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.
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