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: 
CO: OncoGenex Pharmaceuticals, Inc.
ST: British Columbia
-0- Apr/23/2014 10:01 GMT
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