OGX-011 gets on FDA “fast track”


OncoGenex Pharmaceuticals announced today that OGX-011 (custirsen sodium) received Fast Track designation from the U.S. Food & Drug Administration in combination with docetaxel for potential treatment of progressive metastatic prostate cancer. OGX-011 is currently completing Phase II clinical studies in prostate and other cancers. The drug is designed to inhibit the production of a specific protein, clusterin, associated with treatment resistance.

We had already reported on the available data from Phase II prostate cancer trials that were presented at the ASCO annual meeting earlier this year. Phase III trials can be expected to start in the relatively near future.

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