OncoGenex Announces Multiple 'Trials in Progress' Presentations at the 2013 ASCO Annual Meeting

BOTHELL, Wash. and VANCOUVER, British Columbia, May 22, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), a leader in the development of novel therapeutics to target mechanisms of treatment resistance in cancer, today announced that four trials of its investigational compounds, custirsen and OGX-427, will be presented as "Trials in Progress" posters at the 49^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL from May 31 – June 4.

Despite the availability of drugs that improve survival in patients with cancer, treatment failure attributed to resistance continues to be a major problem in medical oncology.^1,2,3,4  Across multiple tumor types, the majority of patients with cancer are likely to face treatment resistance at some point.^4,5,6

"At this year's ASCO we're highlighting the breadth and depth of our clinical development programs, which evaluate innovative therapies that target important mechanisms of cancer treatment resistance in a variety of cancers," said Scott Cormack, President and Chief Executive Officer, OncoGenex Pharmaceuticals, Inc. "With three Phase 3 trials for custirsen ongoing and multiple Phase 2 trials for OGX-427 underway, our development programs have never been stronger."

At ASCO, details will be presented on trial design and rationale for the Phase 3 AFFINITY trial. Additionally, three of five Phase 2 trials from the OGX-427 ORCA™ (Ongoing Studies Evaluating Treatment Resistance in CAncer) clinical trial program will be highlighted. 

• Abstract #TPS5103: Design of the AFFINITY study: A randomized phase III study of a novel clusterin inhibitor, custirsen, plus cabazitaxel/prednisone (CbzP) versus CbzP alone as second-line chemotherapy in metastatic castration-resistant prostate cancer (mCRPC) (June 3, 2013)
• Abstract #TPS4588^: The Borealis-2 clinical trial: A randomized phase II study of OGX-427 plus docetaxel versus docetaxel alone in relapsed/refractory metastatic urothelial cancer (June 3, 2013)
• Abstract #TPS8120: Double-blind randomized phase II trial of carboplatin and pemetrexed with or without OGX-427 in patients with previously untreated stage IV non-squamous non-small-cell lung cancer (NSCLC): The Spruce Clinical Trial (June 1, 2013)
• Abstract #TPS5101: The Pacific trial: A randomized phase II study of OGX-427 in men with metastatic castration-resistant prostate cancer (mCRPC) and PSA progression while receiving abiraterone acetate (AA) (June 3, 2013)

Visit the OncoGenex booth, #22030, at ASCO to find out more about the ORCA and custirsen clinical trial programs.

ABOUT CUSTIRSEN
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. 

The primary registration Phase 3 SYNERGY trial, designed to evaluate a survival benefit for custirsen in combination with first-line docetaxel chemotherapy in men with metastatic CRPC, completed enrollment in 2012. OncoGenex recently announced the SYNERGY trial is continuing as planned per the recommendation of an independent Data Monitoring Committee after completion of the last planned futility analyses.

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 aiming to demonstrate whether inhibition of heat shock protein 27 (Hsp27) can lead to improved prognosis and treatment outcomes for patients with specific types of cancer. Phase 2 clinical trials are underway in bladder, lung, pancreatic and prostate cancers, with additional updates to the ORCA program expected to be provided later 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. 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.

ORCA™, Pacific™, Borealis-2™ and Spruce™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.

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² Mellor HR, Callaghan R. Resistance to chemotherapy in cancer: a complex and integrated cellular response. Pharmacology. 2008;81(4):275-292.

³ Longley DB, Johnston PG. Molecular mechanisms of drug resistance. J Pathol. 2005;205(2):275-292.

⁴ Lippert TH, Ruoff H-J, Volm M. Current status of methods to assess cancer drug resistance. Int J Med Sci. 2011;8(3):245-253.

⁵ Zoubeidi A, Chi K, Gleave M. Targeting the cytoprotective chaperone, clusterin, for treatment of advanced cancer. Clin Cancer Res. 2010;16(4):1088-1093.

⁶ Wilson TR, Longley DB, Johnston PG. Chemoresistance in solid tumours. Ann Oncol. 2006;17(suppl 10):x315-x324.

SOURCE OncoGenex Pharmaceuticals, Inc.