OncoGenex Pharmaceuticals, Inc. (OGXI) announced that it’s experimental product, OGX-011, also known as custirsen sodium, received fast track designation from the U.S. Food & Drug Administration (FDA) for the treatment of progressive metastatic prostate cancer in combination with first-line docetaxel treatment (chemotherapy). OGXI had previously received this same designation for second-line docetaxel treatment with OGX-011 in combination with docetaxel for treatment of progressive metastatic prostate cancer following docetaxel treatment.
Fast track designation is granted to products that the FDA believes might provide a significant improvement in either the safety or effectiveness of the treatment for a serious or life-threatening disease. With this designation, the FDA is obligated to take quick actions with the goal of expediting the development and review of the drug in question.
OGXI has announced their intention to begin Phase 3 clinical trials for first-line and second-line chemotherapy treatments of prostate cancer. The company is hoping that the fast track designations will expeditiously move the trials towards completion and a quick evaluation by the FDA.
In a phase II clinical trial, OGX-011 in combination with docetaxel and prednisone (“the OGX-011 arm”) was compared to docetaxel and prednisone alone (“the control arm”) for first-line treatment of metastatic castrate resistant prostate cancer. The 10.6-month median overall survival advantage observed in the OGX-011 arm represents an increase over the median survival observed in the control arm. The FDA based on a survival advantage of 2.4 months over Mitoxantrone approved Docetaxel.
OGX-011 is a drug “on the horizon” that we should keep our eyes on.
Joel T Nowak MA, MSW