BOTHELL, Wash., and VANCOUVER, British Columbia, Aug. 7, 2012 -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that it has initiated patient enrollment in its second Phase 3 clinical trial evaluating custirsen in patients with advanced prostate cancer. The AFFINITY trial will evaluate if custirsen when combined with second-line chemotherapy has the potential to improve survival outcomes for prostate cancer patients compared to second-line chemotherapy alone.
This Phase 3 trial is an international, randomized, open-label study that will enroll approximately 630 men with CRPC who received first-line docetaxel chemotherapy and have disease progression. Patients will be randomized to receive custirsen, cabazitaxel and prednisone or cabazitaxel and prednisone alone. The primary endpoint of the study is overall survival. Additional analyses will evaluate disease progression parameters and quality of life.
"The prostate cancer treatment landscape continues to evolve, and it is critical that we explore opportunities for combining custirsen with relevant agents throughout the continuum of care," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "The AFFINITY trial has the potential to expand custirsen's ability to combine with an additional taxane, cabazitaxel, and improve the survival outcome of patients with prostate cancer."
Custirsen has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treatment of patients with CRPC receiving first-line docetaxel chemotherapy. The Phase 3 SYNERGY study, evaluating a survival benefit in the first-line CRPC setting, continues to accrue patients and is expected to complete enrollment later this year. Additionally, OncoGenex recently announced that a Phase 3 study in patients with non-small cell lung cancer will begin in the second half of this year.
PR Newswire