BOTHELL, Wash. and VANCOUVER, British Columbia, Dec. 16, 2014 /CNW/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that patient enrollment has been completed in the Rainier™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer. Rainier is sponsored and led by the Sarah Cannon Research Institute (SCRI) and is being conducted at 11 sites in the United States.
In the Rainier trial, 132 patients were randomized to receive either apatorsen or placebo in combination with ABRAXANE and gemcitabine therapy. The primary objective of the trial is overall survival (OS), with additional analyses to evaluate progression-free survival (PFS), tumor response rates, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.
"We are grateful to the patients for their participation in the Rainier trial, which enables us to better understand the role of apatorsen in treating pancreatic cancer," stated Johanna Bendell, MD, Director of the GI Cancer Research Program at SCRI and one of the trial's primary investigators. "Pancreatic cancer continues to be the fourth leading cause of cancer death in the U.S., and there is a need for investigation of additional therapies to improve survival."
About Pancreatic Cancer
Pancreatic cancer accounts for approximately 338,000 new cases each year worldwide. In the U.S., an estimated 46,400 people will be diagnosed with pancreatic cancer, and approximately 39,600 will die from the disease in 2014. Unfortunately, most pancreatic cancer patients will die within the first year of diagnosis, and five-year survival rates are less than 10 percent, demonstrating the need for new therapies with improved efficacy.
About Apatorsen and ORCA™
Apatorsen (OGX-427) is a once-weekly intravenous (IV) experimental drug that is designed to inhibit production of heat shock protein 27 (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. Both the potential single-agent activity and synergistic activity of apatorsen with cancer treatments may increase the overall benefit of existing therapies and augment the durability of treatment outcomes, which could lead to increased patient survival.
The ORCA (Ongoing Studies Evaluating Treatment Resistance in CAncer) program encompasses clinical trials of apatorsen. Phase 2 clinical trials are underway in bladder, lung, pancreatic and prostate cancers. For more information on apatorsen and ORCA, please visit www.OncoGenex.com or www.orcatrials.com.
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. have entered a global collaboration and licensing 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. 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 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 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.
Rainier™ and ORCA™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.
ABRAXANE® is a registered trademark of Celgene Corporation.
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SOURCE OncoGenex Pharmaceuticals, Inc.
For further information: OncoGenex Contact: Jim DeNike, [email protected], +1-425-686-1514, http://www.oncogenex.com