Custirsen is designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance. In 2009, Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. entered into a global license and collaboration agreement to develop and commercialize custirsen. The global Phase 3 clinical programs include both the ongoing SATURN Phase 3 trial assessing durable pain palliation as the primary endpoint for second-line chemotherapy in men with metastatic CRPC and the upcoming SYNERGY Phase 3 trial assessing survival as the primary endpoint in men with metastatic CRPC receiving first-line chemotherapy. A third 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 global clinical program to commercialize custirsen.
More information on the SATURN trial is available on the OncoGenex website at http://oncogenex.com/clinicalTrials/index.html.
Custirsen has received Fast Track designation from the U.S. Food and Drug Administration (FDA). Both the Prostate Cancer SATURN trial and the SYNERGY trial are being conducted through the Special Protocol Assessment (SPA) process. In addition, the European Medicines Agency indicated that the Committee for Medicinal Products for Human Use was in overall agreement with the custirsen development plan for commercialization.
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new cancer therapies that address treatment resistance in cancer patients. OncoGenex has a deep oncology pipeline
|SOURCE OncoGenex Pharmaceuticals, Inc.|
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