OncoGenex' OGX-011 receives additional FDA Fast Track Designation for treating metastatic prostate cancer

Oct 6 2009

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that OGX-011, also known as custirsen sodium, received an additional Fast Track Designation from the U.S. Food & Drug Administration (FDA) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment. OncoGenex had previously received Fast Track Designation for second-line docetaxel treatment with OGX-011 in combination with docetaxel for treatment of progressive metastatic prostate cancer following docetaxel.

Fast Track Designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Based on this designation, the FDA will take actions as appropriate to expedite the development and review of OGX-011 for approval. These actions include scheduled meetings to obtain FDA input into development plans, and the option of submitting a New Drug Application in sections rather than all components simultaneously.

"An expansion of the current Fast Track Designation to include OGX-011 in combination with first-line docetaxel treatment, in addition to second-line docetaxel treatment of patients with progressive metastatic prostate cancer, is consistent with our current development plans in prostate cancer," said Scott Cormack, Chief Executive Officer of OncoGenex Pharmaceuticals. "We intend to execute Phase 3 clinical trial protocols, which now have completed Special Protocol Assessments (SPA's) for first-line and second-line chemotherapy treatment, and these Fast Track Designations along with the SPA's should help us move expeditiously toward commercialization of OGX-011 in prostate cancer."

The request for Fast Track designation was based on data from the randomized, Phase 2 study (Study OGX-011-03) that suggested OGX-011 in combination with first-line docetaxel treatment may improve survival in patients with castrate resistant prostate cancer (CRPC). The median overall survival in patients with CRPC who were treated with OGX-011 plus first-line docetaxel was 23.8 months (95% Confidence Interval (CI) from 16.2 to infinity) compared to 16.9 months (95% CI from 12.8 to 25.8) for patients treated with docetaxel alone with a hazard ratio of 0.61 (95% CI from 0.36 to 1.02).