FDA Agrees with OncoGenex' Phase 3 AFFINITY Protocol Amendment

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Go back to FDA Agrees with OncoGenex' Phase 3 AFFINITY Protocol Amendment

OncoGenex Pharma (OGXI) Announces FDA Agreement on Proposed Phase 3 AFFINITY Amendment

June 10, 2015 7:02 AM EDT

OncoGenex Pharma (NASDAQ: OGXI) announced that the U.S. Food and Drug Administration (FDA) has agreed to the Company's proposed amendment to the Phase 3 AFFINITY protocol and statistical analysis plan. The amendment includes the addition of a co-primary endpoint designed to prospectively evaluate the survival benefit of custirsen in men who are at increased risk for poor outcomes when treated with cabazitaxel for metastatic castrate-resistant prostate cancer (CRPC).

"There are limited effective treatment options for men with metastatic CRPC who have risk factors for poor outcomes and who fall into a poor prognosis... More