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.
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.
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.
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