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OncoGenex Pharmaceuticals Inc. Announces That the Borealis-2™ Clinical Trial of OGX-427 in Previously Treated Metastatic Bladder Cancer is Now Open for Enrollment


4/30/2013 10:40:47 AM

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BOTHELL, Wash. and VANCOUVER, British Columbia, April 30, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Borealis-2 clinical trial, an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy treatment.

Borealis-2 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 endpoint of the trial is overall survival, with secondary objectives to evaluate safety, tolerability, tumor response rates and the effect of therapy on heat shock protein (Hsp27) levels and circulating tumor cells.

"Resistance to initial chemotherapy is a frequent occurrence in patients with advanced bladder cancer, and is often frustrating for physicians and devastating for patients who have limited treatment options available," stated Noah M. Hahn MD, Associate Professor of Medicine at Indiana University Simon Cancer Center and one of the primary investigators on the trial. "We hope that this trial will shed new light on the role of Hsp27 in bladder cancer and the ability of OGX-427 to work synergistically with second- or third-line chemotherapy to overcome resistance and prolong survival."

Borealis-2 is the second randomized, controlled clinical trial of OGX-427 in advanced bladder cancer. Borealis-1 is a company-sponsored, randomized, placebo-controlled Phase 2 trial of OGX-427 in combination with first-line gemcitabine and cisplatin in patients with metastatic 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 trial of OGX-427 in bladder cancer as part of the ORCA program.

Borealis-2 is being conducted at approximately 30 sites in the U.S. and is 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 trial. Please visit http://clinicaltrials.gov/show/NCT01780545 for more information.

ABOUT BLADDER CANCER
Nearly 400,000 cases of bladder cancer are diagnosed per year, worldwide. Approximately 30 percent of patients have locally invasive or metastatic disease at the time of diagnosis, and 50 percent of patients with locally invasive disease relapse with metastases within two years. Limited options exist for both the first- and second-line treatment of advanced bladder cancer. 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.

ABOUT OGX-427 and ORCA
OGX-427 is a once-weekly intravenous (IV) drug that is designed to inhibit production of heat shock protein (Hsp27) to disable cancer cells' defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes.

The ORCA (Ongoing Studies Evaluating Treatment Resistance in CAncer) program encompasses clinical trials of OGX-427. Phase 2 clinical trials are underway in bladder, lung and prostate cancers, with additional trials 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, 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 candidates 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.

Borealis-1, Borealis-2 and ORCA are registered trademarks of OncoGenex Pharmaceuticals, Inc.

SOURCE OncoGenex Pharmaceuticals, Inc.



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