OncoGenex Announces Initiation of Randomized Phase 2 "PACIFIC" Study of OGX-427 in Combo with Zytiga

OncoGenex Pharmaceuticals, Inc.

announced today the initiation of PACIFIC, an investigator-sponsored, randomized Phase 2 study evaluating OGX-427 in men with metastatic castrate-resistant prostate cancer (CRPC) who are experiencing a rising PSA while receiving Zytiga (abiraterone acetate). The aim of the study is to determine if adding OGX-427 to Zytiga treatment can reverse or delay treatment resistance. Approximately 80 men who are being treated with Zytiga and have evidence of a rising PSA, but no evidence of symptomatic or radiographic progression, will be randomized to either continue treatment with Zytiga and prednisone alone, or have OGX-427 added to the Zytiga and prednisone treatment. Patients will be stratified based on whether they have received prior chemotherapy and will continue on study until symptomatic, radiographic or other documented disease progression occurs. The primary objective will be to compare the two treatment groups for delaying further disease progression while on Zytiga by assessing the progression-free survival (PFS) rate at 60 days after adding OGX-427. Secondary objectives include comparing the treatment arms for PSA responses, objective responses, time to progression, circulating tumor cells (CTCs) and other biomarkers.