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BAY 43-9006 Shown To Delay Disease Progression in Phase 3 Study in Advanced Kidney Cancer Patients
As previously agreed with the U.S. Food and Drug Administration (FDA), the two companies will continue the Phase III study as originally planned to its primary endpoint of overall survival. Bayer and Onyx also intend to submit data from the Phase III study for the upcoming American Society of Clinical Oncology meeting, May 13-17, in Orlando, Florida.
Phase III Summary
The multi-national, placebo-controlled Phase III study recently finished enrolling over 800 patients with advanced kidney cancer. The primary endpoint of the study is overall survival, with disease progression, overall response rate, and safety also being assessed. The pivotal trial was initiated in the fourth quarter of 2003 after a Special Protocol Assessment (SPA) was completed by the FDA.
About BAY 43-9006
BAY 43-9006, a novel investigational drug candidate, has demonstrated both anti-proliferative and anti-angiogenic properties -- two important anticancer activities. In preclinical models, BAY 43-9006 inhibited tumor cell proliferation by targeting the RAF/MEK/ERK signaling pathway at the level of RAF kinase. BAY 43-9006 also exerted an antiangiogenic effect by targeting the receptor tyrosine kinases VEGFR-2 and PDGFR and their associated signaling cascades. In addition, BAY 43-9006 also inhibited other tyrosine kinases, including FLT-3 and c-KIT.
Source: Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc.