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
BOTHELL, Wash. and VANCOUVER, British Columbia, Feb. 12, 2013 /CNW/ -
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
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. OncoGenex and Teva
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 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.
Media Contact: Jaime Welch, firstname.lastname@example.org, +1-604-630-5403; Investor
Relations Contact: Susan Specht, email@example.com, +1-425-686-1535
SOURCE: OncoGenex Pharmaceuticals, Inc.
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