BOTHELL, Wash. and VANCOUVER, British Columbia, Sept. 30, 2015 /CNW/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that Borealis-2™, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients. Designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is sponsored by Hoosier Oncology Group and is being conducted at 27 sites across the United States.
Patients enrolled in Borealis-2 were randomized to receive either apatorsen plus docetaxel or doecetaxel alone. Patients could continue weekly apatorsen infusions as maintenance treatment until disease progression or unacceptable toxicity if they completed all 10 planned cycles of docetaxel or discontinued from docetaxel due to toxicity. Evaluation of overall survival is the primary study objective.
"Patients with advanced metastatic bladder cancer, who have failed initial therapies, typically have a poor prognosis with very limited therapeutic options. This is clearly an unmet therapeutic need," said overall principal investigator Toni Choueiri, MD, Clinical Director, Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute. "Recently reported apatorsen data have shown that Hsp27 inhibition improves survival in patients with poor prognosis. We hope to confirm those findings with the Borealis-2 trial results."
Data from the Borealis-1TM trial previously reported at the American Society of Clinical Oncology Annual Meeting earlier this year showed that metastatic bladder cancer patients with poor prognostic features (low performance status, liver involvement, low hemoglobin and high alkaline phosphatase) showed a potential survival benefit with apatorsen 600mg added to first-line chemotherapy (HR = 0.72) compared to chemotherapy alone. Patients in the trial with a Karnofsky Performance Status of 80 percent or less, a common indicator of poor prognosis, experienced a 50 percent reduction in risk of death with the addition of apatorsen therapy (HR = 0.50). Based on findings from the Borealis 1 trial, OncoGenex and the Hoosier Oncology Group plan to evaluate overall survival in patients with poor prognostic factors in the Borealis-2 trial.
"Patients in Borealis-2 are at an increased risk for poor outcomes given their disease has progressed after first-line treatment. Based on recent findings, we are seeing evidence that apatorsen may work in a variety of treatment settings within the bladder cancer paradigm," said Scott Cormack, President and CEO of OncoGenex. "We are thankful to the trial investigators and patients for their participation and we are eager for the results of this trial to inform our broader apatorsen program. We are working closely with investigators to determine next steps given the need and urgency for new bladder cancer treatments."
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 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 regarding the potential benefits and potential development of our product candidates and statements regarding our clinical trial plans and timelines. 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 do 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.
Borealis-1™, Borealis-2™ and ORCA™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.
SOURCE OncoGenex Pharmaceuticals, Inc.
For further information: Jim DeNike, 425.686.1514, [email protected]