OncoGenex Announces Fast Track Designation Granted for Custirsen in Combination with Cabazitaxel/Prednisone as Second-line Chem

 OncoGenex Announces Fast Track Designation Granted for Custirsen in  Combination with Cabazitaxel/Prednisone as Second-line Chemotherapy in Phase 3  AFFINITY Trial of Men with Metastatic Castrate-Resistant Prostate Cancer  Third Phase 3 Trial of Custirsen to Receive FDA Fast Track Designation  BOTHELL, Wash. and VANCOUVER, British Columbia, April 23, 2014 /CNW/ -  OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the U.S.  Food and Drug Administration (FDA) has granted Fast Track designation to the  investigation of custirsen when administered in combination with  cabazitaxel/prednisone for the treatment of men with metastatic  castrate-resistant prostate cancer (CRPC) following prior treatment with a  docetaxel-containing regimen.  Fast track is a process designed to facilitate the development, and expedite  the review, of drugs to treat serious conditions and fill an unmet medical  need.  The purpose is to get important new drugs to the patient earlier.  The international, randomized, open-label Phase 3 AFFINITY trial is designed  to evaluate if custirsen, when combined with second-line chemotherapy  cabazitaxel and prednisone, has the potential to improve survival outcomes for  prostate cancer patients compared to second-line chemotherapy alone. AFFINITY  will enroll approximately 630 men and is expected to complete enrollment in  the second half of 2014.  Custirsen has also received Fast Track designation from the FDA for treatment  of patients with metastatic non-small cell lung cancer as part of the Phase 3  ENSPIRIT trial and for men with metastatic CRPC as part of the Phase 3 SYNERGY  trial. Enrollment in the ENSPIRIT trial is ongoing and top-line survival  results from SYNERGY are expected by mid-2014.  For more information on the AFFINITY trial, including centers currently  enrolling patients, please visit www.prostatecancerstudy.com.  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.  Increased clusterin production has been linked to faster rates of cancer  progression, treatment resistance and shorter survival duration. By inhibiting  clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth  and resistance to partner treatments, so that the benefits of therapy,  including survival, may be extended.  As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to  294 patients with various types of cancer. The majority of adverse events were  mild. The most common adverse events associated with custirsen consisted of  flu-like symptoms. The most common serious adverse events (SAE) associated  with custirsen were febrile neutropenia, fever, pleural effusion, and dyspnea.  Each SAE event was observed in approximately 2%-4% of patients.  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 licensing 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.  Apatorsen is in Phase 2 clinical development and OGX-225 is currently in  pre-clinical development. More information is available at www.OncoGenex.com  and at the company's Twitter account: https://twitter.com/OncoGenex_IR.  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 the potential regulatory timelines and the  potential market opportunity for 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 receive regulatory approval as  or when expected, the risk that our product candidates will not successfully  be commercialized 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.    SOURCE  OncoGenex Pharmaceuticals, Inc.  Media: Jaime Welch, jwelch@oncogenex.com, 604-630-5403; or Investor Relations:  Susan Specht, sspecht@oncogenex.com, 425-686-1535  To view this news release in HTML formatting, please use the following URL:  http://www.newswire.ca/en/releases/archive/April2014/23/c4732.html  CO: OncoGenex Pharmaceuticals, Inc. ST: British Columbia NI: HEA MTC BTC  
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