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OncoGenex Announces Plans for the Initiation of the Borealis-2 Clinical Trial Evaluating OGX-427 in Combination with Second-Line Therapy for Bladder Cancer
Date:2/12/2013

vels in many human cancers including prostate, bladder, breast and non-small cell lung cancer. Overexpression of Hsp27 is thought to be an important factor leading to the development of treatment resistance and is associated with negative clinical outcomes in patients with various tumor types. 

"The launch of Borealis-2 marks OncoGenex' continued commitment to expanding the OGX-427 clinical development program to better understand treatment resistance in GU cancers," said Scott Cormack , President and Chief Executive Officer of OncoGenex. "Given the growing incidence of bladder cancer due to an aging population, we believe there is an urgent need to identify new strategies to address treatment resistance and potentially improve outcomes in this patient population."

Borealis-2 will be the second randomized, controlled clinical trial of OGX-427 in advanced bladder cancer.  The Borealis-1 clinical trial is the OncoGenex-sponsored, randomized, placebo-controlled Phase 2 study designed to evaluate a potential survival benefit, safety and tolerability of combining OGX-427 with gemcitabine and cisplatin in the first-line treatment of patients with advanced bladder cancer. If either Borealis trial shows a survival advantage, OncoGenex plans to initiate conversations with the Food and Drug Administration about the possibility of a Phase 3 study of OGX-427 in bladder cancer as part of the ORCA program. 

About Borealis-2
The Borealis-2 clinical trial will randomize approximately 200 patients to receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone. Patients may also continue weekly OGX-427 infusions as maintenance treatment until disease progression or unacceptable toxicity if they complete all 10 planned cycles of docetaxel or are discontinued from docetaxel due to docetaxel toxicity. The primary objective will be overall survival, with secondary objectives evaluating safety, toler
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SOURCE OncoGenex Pharmaceuticals, Inc.
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