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OncoGenex Pharmaceuticals Inc. Announces Plans for the Initiation of the Cedar™ Clinical Trial Evaluating OGX-427 in Combination With Chemotherapy in Advanced Squamous Cell Lung Cancer


5/23/2013 9:26:35 AM

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BOTHELL, Wash. and VANCOUVER, British Columbia, May 23, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating OGX-427 in previously untreated patients with advanced squamous cell lung cancer.

This trial will be the seventh randomized Phase 2 clinical trial evaluating OGX-427 in the treatment of advanced cancers and will investigate whether adding OGX-427 to gemcitabine and carboplatin therapy can extend progression-free survival (PFS) outcomes.

Cedar will randomize approximately 140 patients to receive either OGX-427 plus gemcitabine and carboplatin therapy, or gemcitabine and carboplatin therapy alone. The primary objective will be PFS, with secondary objectives to evaluate tumor response rates, overall survival, safety, tolerability, and health-related quality of life. Additional analyses will be conducted to determine the effect of therapy on heat shock protein 27 (Hsp27) levels and to explore potential biomarkers that may help predict response to treatment.

"Despite recent advances for the treatment of lung cancer, limited progress has been made to improve survival outcomes for patients with squamous cell carcinoma," stated Prof. Peter Schmid MD PhD FRCP, Director of the Barts/Brighton Experimental Cancer Medicine Centre and the primary investigator on the trial. "Given the preclinical evidence demonstrating significant overexpression of Hsp27 in squamous cell lung cancers, the ability of OGX-427 to inhibit the production of this protein that is linked with resistance to chemotherapy, and the viable combination with gemcitabine and carboplatin, we are hopeful that Cedar will provide meaningful data on the potential of OGX-427 to improve survival outcomes in this difficult-to-treat population."

The trial is being conducted by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and will involve 35 centres in the UK.

Cedar will be the second randomized Phase 2 trial of OGX-427 in advanced lung cancer. OncoGenex also recently announced plans to initiate the Spruce trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating OGX-427 in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung cancer (NSCLC). Spruce is being conducted in partnership with the Sarah Cannon Research Institute (SCRI) and is expected to begin enrollment later this year.

ABOUT LUNG CANCER
Lung cancer is the most common cancer worldwide, with approximately 1.6 million new cases per year. It is the leading cause of cancer death among both men and women in the United States, with approximately 160,000 people expected to die from the disease in 2013. About 80 percent of all lung cancers are identified as non-small cell lung cancer (NSCLC), and a majority of these are metastatic, or advanced, at diagnosis. Non-squamous histology NSCLC includes adenocarcinoma and large cell carcinoma, and accounts for more than half of all diagnoses. Squamous histology NSCLC accounts for about 25 to 30 percent of all lung cancer cases. Although specific targeted therapy has been identified for a minority of patients, chemotherapy remains the backbone of treatment for the majority of patients with lung cancer.

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, pancreatic and prostate cancers. 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, Cedar and Spruce are registered trademarks of OncoGenex Pharmaceuticals, Inc.

SOURCE OncoGenex Pharmaceuticals, Inc.



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