OncoGenex Announces Top-Line Survival Results of Phase 3 SYNERGY Trial Evaluating Custirsen for Metastatic Castrate-Resistant

    OncoGenex Announces Top-Line Survival Results of Phase 3 SYNERGY Trial
    Evaluating Custirsen for Metastatic Castrate-Resistant Prostate Cancer

PR Newswire

BOTHELL, Wash. and VANCOUVER, British Columbia, April 28, 2014

BOTHELL, Wash. and VANCOUVER, British Columbia, April 28, 2014 /PRNewswire/ --
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced results from
the Phase 3 SYNERGY trial. Top-line survival results indicate that the
addition of custirsen to standard first-line docetaxel/prednisone therapy did
not meet the primary endpoint of a statistically significant improvement in
overall survival in men with metastatic castrate-resistant prostate cancer
(CRPC), compared to docetaxel/prednisone alone (median survival 23.4 months vs
22.2 months, respectively; hazard ratio 0.93 and one-sided p value 0.207). The
adverse events observed were similar to custirsen's known adverse event
profile.

"The results of SYNERGY are unexpected, particularly given the wealth of
scientific evidence supporting the targeting of clusterin to combat treatment
resistance in first-line prostate cancer," said Scott Cormack, President and
CEO of OncoGenex. "A thorough analysis of the data is underway to understand
the potential factors that may have contributed to the results. Importantly,
we remain strong in our belief that targeting mechanisms of treatment
resistance is a critical path forward in the fight against cancer and we
continue to actively pursue this approach through the two ongoing Phase 3
trials of custirsen and the seven Phase 2 trials of apatorsen in four tumor
types. We would like to thank the men who participated in the SYNERGY trial
and the friends and families who supported them." 

OncoGenex will host a conference call and live webcast at 7:30 a.m. ETthis
morning.

To access the webcast, log on to the Investor Relations page of the OncoGenex
website atwww.oncogenex.com. Alternatively, you may access the live
conference call by dialing (877) 606-1416(U.S. &Canada) or(707)
287-9313(International).

A webcast replay will be available approximately two hours after the call and
will be archived onwww.oncogenex.comfor 90 days.

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 SYNERGY
The SYNERGY trial enrolled 1,022 men with mCRPC at more than 130 cancer
centers throughout North America, Europe, Israel and South Korea. In the
investigational arm of the trial, custirsen was administered as a weekly
infusion of 640 mg following three loading doses, in combination with
docetaxel and prednisone given as standard 3-week cycles. Patients in the
active comparator arm received docetaxel and prednisone without custirsen. In
both arms, patients were treated until disease progression, unacceptable
toxicity, or completion of up to 10 cycles, unless additional cycles were
deemed beneficial. ^ Full efficacy and safety data from SYNERGY will be
submitted for presentation at an upcoming scientific conference.

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. OncoGenexandTeva Pharmaceutical
Industries Ltd. have entered a global collaboration and licensing agreement to
develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen
utilizes second-generation antisense technology, licensed from Isis
Pharmaceuticals (NASDAQ: ISIS), to effectively target and inhibit production
of clusterin. OncoGenex and Isis partnered in the successful discovery of
custirsen and in its initial development. 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
benefits 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 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.

Website: http://www.OncoGenex.com
Contact: Media: Jaime Welch, jwelch@oncogenex.com, 604-630-5403; Investor
Relations Contact: Susan Specht, sspecht@oncogenex.com, 425-686-1535
 
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