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news.OncoGenex Pharmaceuticals has announced that OGX-011, also known as custirsen sodium, received fast track designation from the FDA in combination with docetaxel for progressive metastatic prostate cancer.
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OGX-011 is currently completing five Phase II clinical studies in prostate, lung and breast cancer, and is designed to inhibit the production of a specific protein, clusterin, associated with treatment resistance.
The request for fast track designation was based on data from Phase II studies in hormone-refractory prostate cancer as well as supporting data in non-small cell lung cancer indicating that OGX-011 treatment can significantly reduce serum clusterin levels and that achieving low serum clusterin levels during treatment is correlated with improved survival.
Scott Cormack, CEO of OncoGenex, said: “Obtaining fast track designation for custirsen sodium while developing our Phase III program for hormone-refractory prostate cancer and in advance of initiating our Phase III study is very important and should help us move forward expeditiously on our pathway toward commercialization.”