OncoGenex Announces Plans For The Initiation Of The Spruce™ Clinical Trial Evaluating OGX-427 In Combination With Chemotherapy In Advanced Non-Squamous Non-Small Cell Lung Cancer
BOTHELL, Wash. and VANCOUVER, British Columbia, April 11, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled Phase 2 study evaluating OGX-427 in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC). The trial will investigate whether adding OGX-427 to carboplatin and pemetrexed therapy can extend progression-free survival (PFS) outcomes.
The Spruce clinical trial 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 will be PFS, with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability, and the effect of therapy on heat shock protein 27 (Hsp27) levels.
"A majority of patients do not have specific markers for targeted therapy and will still receive broad-spectrum treatments, like chemotherapy. There is an urgent need to improve upon outcomes for these patients," stated David Spigel MD, Director of the Lung Cancer Research Program, Sarah Cannon Research Institute (SCRI), and the primary investigator on the study. "By targeting Hsp27 with an innovative therapy like OGX-427, we hope we can delay or prevent treatment resistance and extend the overall survival benefit currently provided by chemotherapy."
Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to treatment resistance and more aggressive cancer phenotypes. OGX-427 is a once-weekly intravenous (IV) drug that is designed to inhibit production of Hsp27 to disable cancer cells' defenses and overcome treatment resistance.Spruce will be the fifth Phase 2 clinical trial evaluating OGX-427 in the treatment of advanced cancers. The study is being sponsored by the SCRI and will be conducted at approximately 20 sites within the SCRI network in the United States. 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 25 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 ORCA™ The ORCA (Ongoing studies evaluating treatment Resistance in CAncer) program encompasses clinical studies of OGX-427 aiming to demonstrate that inhibition of Hsp27 can lead to improved prognosis and treatment outcomes for cancer patients. Phase 2 clinical trials are underway in prostate and bladder cancers, with additional studies expected to initiate this year. For more information on OGX-427 and ORCA, please visit www.oncogenex.com. ABOUT ONCOGENEXOncoGenex 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. 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. Spruce and ORCA are registered trademarks of OncoGenex Pharmaceuticals, Inc.
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