OncoGenex Announces Apatorsen Phase 2 Borealis-2 Trial Continues Following Successful Completion of Futility AnalysisThursday, December 10, 2015
Data Safety Monitoring Board Recommends Continuation of Trial as Planned in Bladder Cancer Patients
Vancouver, BC, December 10, 2015--(T-Net)--OncoGenex Pharmaceuticals, Inc. (OGXI) announced today that the independent Data Safety Monitoring Board (DSMB) at Dana-Farber/Harvard Cancer Center has recommended that the Phase 2 Borealis-2™ trial continue as planned after completing the pre-specified futility analysis.
Borealis-2 is evaluating apatorsen in combination with docetaxel treatment in patients with metastatic bladder cancer. It is the third clinical trial assessing the ability of apatorsen to improve outcomes for patients in this tumor type. Previously, encouraging results were observed in the Borealis-1™ trial evaluating apatorsen in combination with standard of care chemotherapy in metastatic bladder cancer, as well as a trial evaluating apatorsen as monotherapy in patients with non-muscle invasive (superficial) disease.
Investigators have concluded in the bladder cancer trials conducted to date that 600mg apatorsen administered intravenously and all apatorsen doses administered intravesically have been well tolerated. Clinical trials of apatorsen across four tumor types involving over 700 patients have been conducted or are currently ongoing with patient safety monitored throughout the course of these trials.
"We are pleased with the DSMB's recommendation to continue the Borealis-2 trial and we look forward to final results expected in 2016," said Scott Cormack, President and Chief Executive Officer of OncoGenex.
"Additionally, early next year we will receive regulatory feedback on our apatorsen clinical trial design and development strategy for patients with non-muscle invasive bladder cancer."
Borealis-2 is an investigator-sponsored, randomized Phase 2 trial evaluating a survival benefit with apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in approximately 200 patients with metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. The trial is being coordinated by the Hoosier Cancer Research Network at 27 sites across the United States.
In addition to Borealis-2, OncoGenex expects to announce progression-free survival results for the Phase 2 Spruce™ trial in the first quarter of 2016 with continued overall survival follow up.
The company's other asset, custirsen, is currently being evaluated in two ongoing Phase 3 clinical trials. The Phase 3 ENSPIRIT trial is evaluating the ability of custirsen, in combination with docetaxel treatment as second-line chemotherapy, to extend survival in patients with metastatic NSCLC. ENSPIRIT passed a rigorous final futility survival analysis in July and the trial is continuing as planned. Based on current enrollment projections, ENSPIRIT results could be available in the second half of 2016.
The Phase 3 AFFINITY trial is evaluating the ability of custirsen, in combination with cabazitaxel as second-line chemotherapy, to extend survival in men with metastatic CRPC whose disease has progressed following treatment with docetaxel. Final results from the AFFINITY trial for the intent-to-treat population are expected in the second half of 2016.
About Bladder Cancer
Worldwide, more than 429,000 cases of bladder cancer are diagnosed each year, and nearly 75,000 cases of bladder cancer will be diagnosed in the U.S. in 2015. Approximately 70 percent of patients present with superficial or non-muscle-invasive bladder cancer, with about 30 percent of patients having locally invasive or metastatic disease at the time of diagnosis. Of patients with locally invasive disease, 50 percent will relapse with metastases within two years. Limited options exist for both first- and second-line treatment of advanced bladder cancer and there continues to be a high unmet need for additional therapeutic options for this patient population.
About Apatorsen and ORCA™
Apatorsen (OGX-427) is designed to inhibit production of heat shock protein 27 (Hsp27), 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. Phase 2 clinical trials are underway in bladder, lung 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. 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 atwww.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 regarding timing for clinical trial milestones 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 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 we are unable to raise on acceptable terms the capital needed to complete our clinical trials, the risk that our product candidates do not demonstrate the hypothesized or expected benefits 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.
Borealis-2™, Spruce™ and ORCA™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.
Vancouver, BC (Biotech/Life Sciences)
OncoGenex Technologies Inc.
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