OncoGenex Announces Plans for the Initiation of the Rainier™ Clinical Trial
Evaluating OGX-427 in Combination with ABRAXANE® plus Gemcitabine in Patients
with Metastatic Pancreatic Cancer
Pancreatic Cancer Becomes the Fourth Tumor Type Evaluated as Part of the
OGX-427 ORCA™ Program, In Addition to Bladder, Lung and Prostate Cancers
BOTHELL, Wash. and VANCOUVER, British Columbia, May 1, 2013 /CNW/ - OncoGenex
Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation
of the Rainier™ trial, an investigator-sponsored, randomized,
placebo-controlled Phase 2 trial evaluating OGX-427 in combination with
ABRAXANE(®) (paclitaxel protein-bound particles for injectable
suspension)(albumin-bound) and gemcitabine in patients with previously
untreated metastatic pancreatic cancer.
Rainier will randomize approximately 130 patients to receive either OGX-427 or
placebo in combination with ABRAXANE and gemcitabine therapy. The primary
endpoint of the trial will be overall survival, with additional analyses to
evaluate progression-free survival (PFS), tumor response rates, safety,
tolerability, and the effect of therapy on heat shock protein (Hsp27) levels.
"Based on the positive survival results demonstrated by the Phase 3 MPACT
(Metastatic Pancreatic Adenocarcinoma Clinical Trial) trial, many patients
with advanced pancreatic cancer will undoubtedly receive treatment with
gemcitabine plus ABRAXANE in the future. However, survival times remain short
for these patients, and we need to continue to explore new strategies to
address treatment resistance," stated Andrew H. Ko MD, Associate Professor of
Medicine, Division of Hematology/Oncology at the University of California, San
Francisco, and a primary investigator on the trial. "The Rainier trial
provides us the opportunity to explore the role of Hsp27 in pancreatic cancer,
and the potential ability of OGX-427 to improve on clinical outcomes when
added to combination chemotherapy."
The trial is being sponsored by the Sarah Cannon Research Institute (SCRI) and
will be conducted at approximately 12 sites in the United States. Dr. Andrew
H. Ko from the University of California, San Francisco, and Dr. Johanna
Bendell, Director, GI Cancer Research Program at SCRI, will serve as the
primary investigators on the trial. "We are very excited to bring this trial
of an exciting novel agent to patients with metastatic pancreatic cancer, who
desperately need more treatment options," said Dr. Bendell.
ABOUT PANCREATIC CANCER Pancreatic cancer accounts for approximately 279,000
new cases each year worldwide. In the United States, an estimated 45,000
people will be diagnosed with pancreatic cancer and approximately 38,500 will
die from the disease in 2013. Most pancreatic cancer patients will die within
the first year of diagnosis, and five-year survival rates are only about 6
percent. An estimated 85 to 90 percent of patients present with locally
advanced or metastatic disease. Median five-year survival for patients
diagnosed with stage IV disease is just 4.5 months, demonstrating the need for
new therapies with improved efficacy.
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, pancreatic and prostate cancers, with additional updates to
the ORCA program expected to be provided later 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.
ABOUT SCRI Sarah Cannon Research Institute (SCRI) is a global strategic
research organization focusing on advancing therapies for patients. It is one
of the largest clinical research programs, conducting community-based clinical
trials in oncology and cardiology through affiliations with a network of more
than 700 physicians in the United States and United Kingdom. Additionally,
SCRI offers management, regulatory and other research support services to drug
development sponsors and strategic investigator sites. For more information,
please visit sarahcannonresearch.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.
ABRAXANE(®) is a registered trademark of Celgene Corporation. ORCA™ and
Rainier™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.
Media: Jaime Welch, firstname.lastname@example.org, 604-630-5403; Investor Relations:
Susan Specht, email@example.com, 425-686-1535
SOURCE: OncoGenex Pharmaceuticals, Inc.
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