BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 1, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Spruce™ clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled Phase 2 trial evaluating OGX-427, a heat shock protein 27 (Hsp27) inhibitor, in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).
Spruce will randomize approximately 155 patients with non-squamous NSCLC to receive either OGX-427 plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy. Patients may also continue maintenance therapy with pemetrexed and/or OGX-427/placebo until disease progression or unacceptable toxicity. The primary objective of the trial is progression-free survival (PFS), with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability, and the effect of therapy on Hsp27 levels.
"There continues to be an urgent need for a majority of patients with lung cancer who lack specific biomarkers and will receive non-targeted treatments like chemotherapy," stated David Spigel MD, Director of the Lung Cancer Research Program, Sarah Cannon Research Institute (SCRI), and the primary investigator on the trial. "We hope that opening this trial will lead to us better understanding the role of Hsp27 in non-small cell lung cancer, and the ability of OGX-427 to work with chemotherapies in order to delay or prevent treatment resistance and improve survival outcomes for these patients."
Spruce is sponsored by SCRI and will be conducted at approximately 20 sites within the SCRI network in the United States. Visit http://clinicaltrials.gov/show/NCT01829113 for more information. Spruce is one of six Phase 2 clinical trials in the ORCA™ Program evaluating OGX-427 in the treatment of advanced cancers, and the first of two randomized Phase 2 trials of OGX-427 in NSCLC to open. OncoGenex also recently announced plans to initiate the Cedar™ clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating OGX-427 in patients with previously untreated, advanced, squamous cell lung cancer. Cedar is being conducted in partnership with the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and is expected to begin enrollment later this year.
ABOUT LUNG CANCER
Lung cancer is the most common cancer worldwide, with approximately 1.6 million new cases per year. It is the leading cause of cancer death among both men and women in the United States, with approximately 160,000 people expected to die from the disease in 2013. About 80 percent of all lung cancers are identified as non-small cell lung cancer (NSCLC), and a majority of these are metastatic, or advanced, at diagnosis. Non-squamous histology NSCLC includes adenocarcinoma and large cell carcinoma, and accounts for more than half of all diagnoses. Squamous histology NSCLC accounts for about 20 to 30 percent of all lung cancer cases. Although specific targeted therapy has been identified for a minority of patients, chemotherapy remains the backbone of treatment for the majority of patients with lung cancer.
ABOUT OGX-427 and ORCA™
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 OGX-427 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 OGX-427. The ORCA program has recently expanded to encompass six Phase 2 trials in bladder, lung, pancreatic and prostate cancers. For more information on OGX-427 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. 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.
Spruce™, Cedar™ and ORCA™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.
SOURCE OncoGenex Pharmaceuticals, Inc.