OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today highlighted key clinical development activities for its two product candidates, custirsen and OGX-427, and announced its fourth quarter and year end 2012 financial results.
Custirsen Clinical Development Highlights o The Company announced completion of patient enrollment of more than 1,000 men in the primary registration Phase 3 SYNERGY study in the fourth quarter of 2012. The SYNERGY study is designed to evaluate a survival benefit for custirsen, in combination with first-line docetaxel chemotherapy, in men with metastatic castrate-resistant prostate cancer (CRPC). The expected timing of results is based on a pre-specified number of death events that is projected to occur in the fourth quarter of 2013, with data results expected to be announced in the first half of 2014. o Patient enrollment began in the third quarter of 2012 in the Phase 3 AFFINITY study, evaluating a survival benefit for custirsen in combination with Jevtana® (cabazitaxel) as second-line chemotherapy. AFFINITY aims to enroll approximately 630 men with CRPC and is being conducted at sites throughout North America, Europe and Australia. o Patient enrollment began in the third quarter of 2012 in the Phase 3 ENSPIRIT trial, a randomized Phase 3 study in approximately 1,100 patients with advanced or metastatic non-small cell lung cancer (NSCLC). ENSPIRIT will evaluate the potential survival benefit of combining custirsen with docetaxel as second-line chemotherapy. Custirsen has also recently received Fast Track designation from the FDA for the second-line treatment of advanced NSCLC when combined with docetaxel in patients with disease progression following treatment with a first-line, platinum-based chemotherapy doublet regimen. OGX-427 Clinical Development Highlights o In December 2012, the Company announced the initiation of the Pacific trial, an investigator-sponsored, randomized Phase 2 study evaluating OGX-427 in approximately 80 men with CRPC who are experiencing a rising prostate-specific antigen (PSA) while receiving Zytiga® (abiraterone acetate). The study is currently enrolling at sites in the United States and Canada. o The company-sponsored, randomized Phase 2 clinical trial of OGX-427 in combination with gemcitabine and cisplatin in patients with metastatic bladder cancer, Borealis-1, continues to enroll patients throughout the United States, Canada and Europe. The study aims to enroll approximately 180 patients and is expected to complete patient accrual in the second half of 2013. o The Company also recently announced plans for the initiation of an investigator-sponsored, randomized Phase 2 study evaluating OGX-427 in patients with advanced or metastatic bladder cancer who have disease progression following initial platinum-based chemotherapy. The trial, Borealis-2, will seek to enroll approximately 200 patients to receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone and is expected to begin in the first half of 2013. o Pacific, Borealis-1 and Borealis-2 are part of the “ORCA” (On-going studies evaluating treatment Resistance in CAncer) program that encompasses clinical studies of OGX-427 across multiple cancer indications. Plans to initiate additional studies as part of the ORCA program will be announced in the coming months.
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