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OncoGenex reports updated survival data on OGX-011 in a second-line chemotherapy trial for patients with prostate cancer

Friday, May 16, 2008 General News J E 4
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VANCOUVER, May 16 /PRNewswire/ - OncoGenex Technologies Inc. announcedtoday that updated Phase 2 data on the Company's lead cancer drug candidate,OGX-011, also referred to as custirsen, revealed encouraging outcomes in thetreatment of patients with hormone refractory prostate cancer. Overall,custirsen was well-tolerated in combination with either docetaxel ormitoxantrone administered as second-line chemotherapy in patients with hormonerefractory prostate cancer and was associated with durable pain responses in50 percent or more of patients, a minimum of a 50 percent PSA decline in 27percent or more of patients, and better than expected survival with 60 percentof patients alive at a median follow-up of 13.3 months. Top line data as ofJanuary 3, 2008 were published online by the American Society of ClinicalOncology (ASCO) in abstract ID # 5002, titled "A phase II randomized study ofcustirsen (OGX-011) combination therapy in patients with poor-risk hormonerefractory prostate cancer (HRPC) who relapsed on or within six months offirst-line docetaxel therapy." Updated data as of May 1, 2008 will bepresented on June 1 at the 2008 Annual Meeting of the American Society ofClinical Oncology by Dr. Fred Saad, Professor of Surgery/Urology at theUniversity of Montreal. OncoGenex and Isis Pharmaceuticals, Inc. (Nasdaq:ISIS) are collaborating on development of OGX-011.

This study was designed as an open-label, randomized, multicenter studyevaluating weekly administration of custirsen in combination with second-linechemotherapy in patients with metastatic hormone refractory prostate cancerwho were previously treated with a minimum of two cycles of docetaxel-basedfirst-line chemotherapy. Patients in this study represented a poor prognosticpopulation due to rapid disease progression after completing first-linedocetaxel therapy. Because custirsen has been shown to enhance chemotherapyand reverse chemotherapy resistance in preclinical in vitro and in vivomodels, the aim of this study was to assess the effect of custirsen incombination with either mitoxantrone or docetaxel retreatment as second-linechemotherapy. Clinical studies that will support product approval are beingplanned utilizing chemotherapy plus custirsen as second-line therapy inpatients progressing after a first-line docetaxel regimen.

About OGX-011

OGX-011 is designed to block production of clusterin, a cell survivalprotein that is over-produced in several cancer indications and in response tomany cancer treatments, including hormone ablation therapy, chemotherapy andradiation therapy. Increased clusterin production is observed in many humancancers, including prostate, non-small cell lung, breast, ovarian, bladder,renal, pancreatic, anaplastic large cell lymphoma and colon cancers andmelanoma. Increased clusterin production is linked to faster rates of cancerprogression, treatment resistance and shorter survival duration. Clusterinlevels may be further increased in response to standard cancer therapies,including hormone ablation therapy, chemotherapy and radiation therapy.Clusterin expression is linked to disease progression, treatment resistance,poor prognosis and survival in scientific publications. For example, increasedexpression of clusterin in prostate cancer is closely correlated withincreasing Gleason score, which is a strong prognostic factor for poorsurvival of patients with prostate cancer.

About OncoGenex

OncoGenex is a private biopharmaceutical company committed to thedevelopment and commercialization of new cancer therapies that addresstreatment resistance in cancer patients. The company's three productcandidates are designed to inhibit the production of specific proteinsassociated with treatment resistance and which are over-produced in responseto a variety of cancer treatments. OGX-011 is completing evaluation in fivePhase 2 clinical studies in prostate, lung, and brea
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