H.I.G. Capital News
OncoGenex Announces Cedar™ Clinical Trial Evaluating Apatorsen in Combination with Chemotherapy in Advanced Squamous Cell Lung Cancer is Now Open for Enrollment
ORCA™ program includes seven Phase 2 trials in tumor types where patient need is acute, including bladder, lung, pancreas and prostate cancers
BOTHELL, WA & VANCOUVER, BC - July 1, 2014 - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Cedar™ clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer. Apatorsen 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.
Approximately 140 patients with previously untreated stage IV or recurrent squamous cell lung cancers or stage IIIB squamous cell cancers that are not amenable to radiochemotherapy will be randomized to receive either apatorsen plus gemcitabine and carboplatin therapy, or gemcitabine and carboplatin therapy alone. The primary objective is progression-free survival (PFS), with secondary objectives to evaluate tumor response rates, overall survival, safety, tolerability, and health-related quality of life. Additional analyses will be conducted to determine the effect of therapy on Hsp27 levels and to explore potential biomarkers that may help predict response to treatment.
"Despite continuing advances for the treatment of lung cancer, progress in improving survival for patients with squamous cell carcinoma has been particularly slow," stated Prof. Peter Schmid MD PhD FRCP, Centre Lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London and the primary investigator on the trial. "Given the depth of preclinical evidence supporting the utility of apatorsen in a broad range of cancers, we are excited to open enrollment in the Cedar trial to shed greater light on the ability of apatorsen to reduce resistance to chemotherapies and improve survival outcomes for patients with squamous cell lung cancer."
Cedar is an investigator-sponsored trial being conducted and funded primarily by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and will involve approximately 20 centers in the United Kingdom. Visit http://public.ukcrn.org.uk (UKCRN #16622) for more information.
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 Apatorsen and ORCA™
Apatorsen is a once-weekly intravenous (IV) experimental drug that is designed to inhibit production of 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. Apatorsen is currently being evaluated in seven randomized Phase 2 trials for a variety of cancers. A majority of the ORCA trials are investigator-initiated and funded through partnership with academic institutions. For more information on apatorsen and ORCA, please visit www.OncoGenex.com or www.ORCAtrials.com. To find an ORCA trial site in the U.S. or Canada, call (toll-free) 1-855-216-0159 or visit MyTrialMatch.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 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, the risk that our cash resources are insufficient to fund our planned activities for the time period expected 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.
ORCA™ and Cedar™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.