Oncothyreon (NASDAQ:ONTY): On 22/06/09, ONTY announced that Merck KGaA (PINK:MKGAY) has initiated a global Phase 3 trial of Stimuvax (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 ONTY. 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. Stimuvax is also being evaluated in a 1300-patient Phase 3 START trial in patients with non-small cell lung cancer with data anticipated in 2011.

A full, detailed report on these developments and how it affects other FDA decisions and approvals is available at BioMedReports.com