OncoGenex Announces Plans for the Initiation of the Borealis-2 Clinical Trial Evaluating OGX-427 in Combination with Second-Line

OncoGenex Announces Plans for the Initiation of the Borealis-2 Clinical Trial 
Evaluating OGX-427 in Combination with Second-Line Therapy for Bladder Cancer 
Company Reaffirms Commitment to Addressing Treatment Resistance in 
Genitourinary (GU) Cancers with Fourth Phase 2 GU trial in OGX-427 ORCA Program 
BOTHELL, Wash. and VANCOUVER, British Columbia, Feb. 12, 2013 /CNW/ - 
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the 
initiation of the Borealis-2 clinical trial, an investigator-sponsored, 
randomized, controlled Phase 2 study evaluating OGX-427 in patients with 
advanced or metastatic bladder cancer who have disease progression following 
initial platinum-based chemotherapy treatment. The trial, which is the fourth 
Phase 2 study of OGX-427 in a genitourinary (GU) cancer, will investigate if 
combining OGX-427 with docetaxel, a standard option in salvage treatment for 
metastatic bladder cancer, improves survival compared to docetaxel alone. 
"Bladder cancer is often sensitive to chemotherapy in the first-line setting, 
but, when patients relapse, resistance to chemotherapy is frequent," stated 
Jonathan Rosenberg MD, Associate Physician, Memorial Sloan-Kettering Cancer 
Center and one of the primary investigators on the study. "This trial will 
evaluate the potential of OGX-427 to work synergistically with second- or 
third-line chemotherapy to overcome treatment resistance and prolong survival 
in patients with advanced bladder cancer." 
Limited options exist for both the first- and second-line treatment of 
advanced bladder cancer. Currently, first-line platinum-based chemotherapy 
regimens result in a median overall survival of approximately 12-15 months. 
Docetaxel is commonly used in second-line treatment, with a reported median 
overall survival of approximately six months. Given acquired treatment 
resistance and these short survival times, there continues to be a high unmet 
need for additional therapeutic options for this patient population. 
OGX-427 is designed to inhibit Heat Shock Protein 27 (HSP27), a cell-survival 
protein found at elevated levels 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, tolerability, tumor 
response rates and the effect of therapy on Hsp27 levels and circulating tumor 
Borealis-2 will be conducted at approximately 30 sites in the U.S. and is 
being sponsored by the Hoosier Oncology Group. Dr. Noah Hahn from the Indiana 
University Simon Cancer Center, Dr. Toni Choueiri from the Dana-Farber Cancer 
Institute and Dr. Jonathan Rosenberg from Memorial Sloan-Kettering Cancer 
Center will serve as the primary investigators on the study. 
ABOUT ORCA The "ORCA" (Overcoming Resistance in CAncer) program encompasses 
the on-going studies of OGX-427 aiming to demonstrate that inhibition of Hsp27 
can lead to improved prognosis and treatment outcomes for cancer patients. 
Phase 2 clinical trials are underway in prostate and bladder cancers, with 
additional studies expected to initiate this year. For more information on 
OGX-427 and ORCA, please visit www.oncogenex.com. 
ABOUT ONCOGENEX OncoGenex is a biopharmaceutical company committed to the 
development and commercialization of new therapies that address treatment 
resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with 
each product candidate having a distinct mechanism of action and representing 
a unique opportunity for cancer drug development. OncoGenex and Teva 
Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global 
collaboration and license agreement to develop and commercialize OncoGenex' 
lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical 
development as a treatment in men with metastatic castrate-resistant prostate 
cancer and in patients with advanced, unresectable non-small cell lung cancer. 
OGX-427 is in Phase 2 clinical development and OGX-225 is currently in 
pre-clinical development. More information is available at www.OncoGenex.com. 
OncoGenex' Forward Looking Statements  This press release contains 
forward-looking statements within the meaning of the "safe harbor" provisions 
of the Private Securities Litigation Reform Act of 1995, including, but not 
limited to, statements concerning our anticipated product development 
activities, such as expected clinical trial completion and design and 
statements regarding the potential benefits and potential development of our 
product candidates. All statements other than statements of historical fact 
are statements that could be deemed forward-looking statements. These 
statements are based on management's current expectations and beliefs and are 
subject to a number of risks, uncertainties and assumptions that could cause 
actual results to differ materially from those described in the 
forward-looking statements. Such forward-looking statements are subject to 
risks and uncertainties, including, among others, the risk that our product 
candidates will not demonstrate the hypothesized or expected benefits, the 
risk of delays in our expected clinical trials, the risk that new developments 
in the rapidly evolving cancer therapy landscape require changes in our 
clinical trial plans or limit the potential benefits of our product, the risk 
that our cash resources are insufficient to fund our planned activities for 
the time period expected and the other factors described in our risk factors 
set forth in our filings with the Securities and Exchange Commission from time 
to time, including the Company's Annual Report on Form 10-K and Quarterly 
Reports on Form 10-Q. The Company undertakes no obligation to update the 
forward-looking statements contained herein or to reflect events or 
circumstances occurring after the date hereof, other than as may be required 
by applicable law. 
Media Contact: Jaime Welch, jwelch@oncogenex.com, +1-604-630-5403; Investor 
Relations Contact: Susan Specht, sspecht@oncogenex.com, +1-425-686-1535 
SOURCE: OncoGenex Pharmaceuticals, Inc. 
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CO: OncoGenex Pharmaceuticals, Inc.
ST: British Columbia
-0- Feb/12/2013 13:01 GMT
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