The OGX-427 ORCA™ Program Continues to Expand with Patient
Enrollment Now Open for Second Phase 2 Trial of OGX-427 in Advanced
Bladder Cancer
BOTHELL, Wash. and VANCOUVER, British Columbia, April 30, 2013 /CNW/ - OncoGenex Pharmaceuticals,
Inc. (NASDAQ: OGXI) today announced initiation of the Borealis-2™
clinical trial, an investigator-sponsored, randomized Phase 2 trial
evaluating OGX-427 in combination with docetaxel in patients with
advanced or metastatic bladder cancer who have disease progression
following first-line platinum-based chemotherapy treatment.
Borealis-2 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
endpoint of the trial is overall survival, with secondary
objectives to evaluate safety, tolerability, tumor response rates
and the effect of therapy on heat shock protein (Hsp27) levels and
circulating tumor cells.
"Resistance to initial chemotherapy is a frequent occurrence in
patients with advanced bladder cancer, and is often frustrating for
physicians and devastating for patients who have limited treatment
options available," stated Noah M.
Hahn MD, Associate Professor of Medicine at Indiana University Simon Cancer Center and one of
the primary investigators on the trial. "We hope that this trial
will shed new light on the role of Hsp27 in bladder cancer and the
ability of OGX-427 to work synergistically with second- or
third-line chemotherapy to overcome resistance and prolong
survival."
Borealis-2 is the second randomized, controlled clinical trial
of OGX-427 in advanced bladder cancer. Borealis-1™ is a
company-sponsored, randomized, placebo-controlled Phase 2 trial of
OGX-427 in combination with first-line gemcitabine and cisplatin in
patients with metastatic 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 trial of OGX-427 in bladder cancer as part
of the ORCA™ program.
Borealis-2 is being conducted at approximately 30 sites in the
U.S. and is 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 trial. Please visit
http://clinicaltrials.gov/show/NCT01780545 for more
information.
ABOUT BLADDER CANCER
Nearly 400,000 cases of bladder
cancer are diagnosed per year, worldwide. Approximately 30 percent
of patients have locally invasive or metastatic disease at the time
of diagnosis, and 50 percent of patients with locally invasive
disease relapse with metastases within two years. Limited options
exist for both the first- and second-line treatment of advanced
bladder cancer. 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.
ABOUT OGX-427 and ORCA™
OGX-427 is a once-weekly
intravenous (IV) drug that is designed to inhibit production of
heat shock protein (Hsp27) to disable cancer cells' defenses and
overcome treatment resistance. Hsp27 is an intracellular protein
that protects cancer cells by helping them survive, leading to
resistance and more aggressive cancer phenotypes.
The ORCA (Ongoing Studies Evaluating Treatment
Resistance in CAncer) program encompasses clinical
trials of OGX-427. Phase 2 clinical trials are underway in bladder,
lung and prostate cancers, with additional trials 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, 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 candidates 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.
Borealis-1™, Borealis-2™ and ORCA™ are registered trademarks
of OncoGenex Pharmaceuticals, Inc.
SOURCE OncoGenex Pharmaceuticals, Inc.