OncoGenex Announces that the Rainier™ Clinical Trial Evaluating Apatorsen (OGX-427) in Combination with ABRAXANE® plus Gemcitabine in Patients with Metastatic Pancreatic Cancer is Now Open for Enrollment Pancreatic Cancer Joins Bladder, Lung and Prostate Cancers as Tumor Types with Phase 2 Trials Open for Enrollment as Part of the ORCA™ Program
BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 29, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Rainier™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen (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 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.
"Median survival for patients with advanced pancreatic cancer continues to need improvement and has prompted us to investigate additional strategies to address treatment resistance," stated Johanna Bendell MD, Director of the GI Cancer Research Program, Sarah Cannon Research Institute (SCRI), and a primary investigator on the trial. "We are very excited to open enrollment in the Rainier trial, to explore the role of Hsp27 in pancreatic cancer and to evaluate apatorsen in combination with chemotherapy."
Rainier is sponsored by SCRI and will be conducted at approximately 12 sites in the United States. Dr. Andrew H. Ko, Associate Professor of Medicine, Division of Hematology/Oncology at the University of California, San Francisco and Dr. Bendell of SCRI are the primary investigators on the trial. Visit http://clinicaltrials.gov/show/NCT01844817 for more information.
About Pancreatic Cancer
Pancreatic cancer accounts for approximately 279,000 new cases each year worldwide. In the US, 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, and median overall survival for patients diagnosed with stage IV disease is just 4.5 months, 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. The ORCA program has recently expanded to encompass six Phase 2 trials 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 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. Apatorsen 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.
Rainier™ and ORCA™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.
ABRAXANE® is a registered trademark of Celgene Corporation.
SOURCE OncoGenex Pharmaceuticals, Inc.