OGX-011/ TV-1011 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) and this SATURN trial is being conducted through the Special Protocol Assessment (SPA) process. Earlier this year, the European Medicines Agency indicated that the Committee for Medicinal Products for Human Use was in overall agreement with the company's development plan for OGX-011/ TV-1011 which included this Phase 3 trial.
In 2009, Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. entered into a global license and collaboration agreement to develop and commercialize OGX-011/TV-1011. In addition to the ongoing SATURN trial assessing durable pain palliation as the primary endpoint for second-line chemotherapy in men with metastatic CRPC, the global Phase 3 clinical program also includes a Phase 3 trial in first-line chemotherapy for metastatic CRPC which assesses survival as the primary endpoint. A Phase 3 trial assessing survival as the primary endpoint in first-line treatment of advanced, unresectable non-small cell lung cancer (NSCLC) is also planned as part of the strategy to develop and commercialize OGX-011/TV-1011.
About Prostate Cancer
The National Cancer Institute reports that in 2009, approximately 192,280 new cases of prostate cancer will be diagnosed in the U.S. As the most frequently diagnosed cancer among men, one in six men will be diagnosed with prostate cancer during their lifetime. It is estimated that in 2009 in the U.S., 27,360 deaths will result due to the disease. The International Agency for Research on Cancer recently published estimates of cancer incidence and mortality in Europe in 2008. They reported 382,300 new cases of prostate cancer and 89,300 deaths related to prostate cancer.
|SOURCE OncoGenex Pharmaceuticals, Inc.|
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