OncoGenex Announces Plans for the Initiation of the Borealis-2 Clinical Trial Evaluating OGX-427 in Combination with Second-Line

OncoGenex Announces Plans for the Initiation of the Borealis-2 Clinical Trial
Evaluating OGX-427 in Combination with Second-Line Therapy for Bladder Cancer

Company Reaffirms Commitment to Addressing Treatment Resistance in
Genitourinary (GU) Cancers with Fourth Phase 2 GU trial in OGX-427 ORCA
Program

PR Newswire

BOTHELL, Wash. and VANCOUVER, British Columbia, Feb. 12, 2013

BOTHELL, Wash. and VANCOUVER, British Columbia, Feb. 12, 2013 /PRNewswire/
--OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for
the initiation of the Borealis-2 clinical trial, an investigator-sponsored,
randomized, controlled Phase 2 study evaluating OGX-427 in patients with
advanced or metastatic bladder cancer who have disease progression following
initial platinum-based chemotherapy treatment. The trial, which is the fourth
Phase 2 study of OGX-427 in a genitourinary (GU) cancer, will investigate if
combining OGX-427 with docetaxel, a standard option in salvage treatment for
metastatic bladder cancer, improves survival compared to docetaxel alone.

"Bladder cancer is often sensitive to chemotherapy in the first-line setting,
but, when patients relapse, resistance to chemotherapy is frequent," stated
Jonathan Rosenberg MD, Associate Physician, Memorial Sloan-Kettering Cancer
Center and one of the primary investigators on the study. "This trial will
evaluate the potential of OGX-427 to work synergistically with second- or
third-line chemotherapy to overcome treatment resistance and prolong survival
in patients with advanced bladder cancer."

Limited options exist for both the first- and second-line treatment of
advanced bladder cancer. Currently, first-line platinum-based chemotherapy
regimens result in a median overall survival of approximately 12-15 months.
Docetaxel is commonly used in second-line treatment, with a reported median
overall survival of approximately six months. Given acquired treatment
resistance and these short survival times, there continues to be a high unmet
need for additional therapeutic options for this patient population.

OGX-427 is designed to inhibit Heat Shock Protein 27 (HSP27), a cell-survival
protein found at elevated levels in many human cancers including prostate,
bladder, breast and non-small cell lung cancer. Overexpression of Hsp27 is
thought to be an important factor leading to the development of treatment
resistance and is associated with negative clinical outcomes in patients with
various tumor types.

"The launch of Borealis-2 marks OncoGenex' continued commitment to expanding
the OGX-427 clinical development program to better understand treatment
resistance in GU cancers," said Scott Cormack, President and Chief Executive
Officer of OncoGenex. "Given the growing incidence of bladder cancer due to an
aging population, we believe there is an urgent need to identify new
strategies to address treatment resistance and potentially improve outcomes in
this patient population."

Borealis-2 will be the second randomized, controlled clinical trial of OGX-427
in advanced bladder cancer. The Borealis-1 clinical trial is the
OncoGenex-sponsored, randomized, placebo-controlled Phase 2 study designed to
evaluate a potential survival benefit, safety and tolerability of combining
OGX-427 with gemcitabine and cisplatin in the first-line treatment of patients
with advanced bladder cancer. If either Borealis trial shows a survival
advantage, OncoGenex plans to initiate conversations with the Food and Drug
Administration about the possibility of a Phase 3 study of OGX-427 in bladder
cancer as part of the ORCA program.

About Borealis-2
The Borealis-2 clinical trial will randomize approximately 200 patients to
receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone.
Patients may also continue weekly OGX-427 infusions as maintenance treatment
until disease progression or unacceptable toxicity if they complete all 10
planned cycles of docetaxel or are discontinued from docetaxel due to
docetaxel toxicity. The primary objective will be overall survival, with
secondary objectives evaluating safety, tolerability, tumor response rates and
the effect of therapy on Hsp27 levels and circulating tumor cells.

Borealis-2 will be conducted at approximately 30 sites in the U.S. and is
being sponsored by the Hoosier Oncology Group. Dr. Noah Hahn from the Indiana
University Simon Cancer Center, Dr. Toni Choueiri from the Dana-Farber Cancer
Institute and Dr. Jonathan Rosenberg from Memorial Sloan-Kettering Cancer
Center will serve as the primary investigators on the study.

ABOUT ORCA
The "ORCA" (Overcoming Resistance in CAncer) program encompasses the on-going
studies of OGX-427 aiming to demonstrate that inhibition of Hsp27 can lead to
improved prognosis and treatment outcomes for cancer patients. Phase 2
clinical trials are underway in prostate and bladder cancers, with additional
studies expected to initiate 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.OncoGenexandTeva Pharmaceutical
Industries Ltd.(NYSE:TEVA) 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. Such forward-looking statements
are subject to risks and uncertainties, 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, the risk that our cash resources are insufficient to fund our planned
activities for the time period expected and the other factors described in our
risk factors set forth in our filings with theSecurities and Exchange
Commissionfrom 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 Contact: Jaime Welch, jwelch@oncogenex.com, +1-604-630-5403;
Investor Relations Contact: Susan Specht, sspecht@oncogenex.com,
+1-425-686-1535
 
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