OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that enrollment has been completed in Borealis-1™, a company-sponsored, randomized, placebo-controlled Phase 2 trial of OGX-427 in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer.
Approximately 180 patients have been randomized into Borealis-1 at 55 clinical sites throughout North America and Europe. The three-arm trial randomized patients to receive gemcitabine, cisplatin, and OGX-427 at two dose-levels (600 mg or 1000 mg) vs. gemcitabine, cisplatin, and placebo. The primary endpoint of the trial is overall survival. Additional analyses will be conducted to evaluate benefit/risk of the two dosing levels using clinical benefit, safety and tolerability outcomes for each dose level.
"There are limited treatment options available for patients with metastatic bladder cancer and completion of enrollment in Borealis-1 brings us closer to validating novel therapies, such as OGX-427, that might overcome treatment resistance and extend survival," stated Cindy Jacobs MD, PhD, Executive Vice President and Chief Medical Officer of OncoGenex. "We expect data results to be available in the second-half of 2014, and if the trial is positive, we will initiate discussion with the Food and Drug Administration regarding next steps."
Borealis-1 is one of two ongoing clinical trials of OGX-427 in metastatic bladder cancer. The Borealis-2™ trial is an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. This trial is sponsored by the Hoosier Oncology Group and currently enrolling patients. For more information, please click here.
About Bladder Cancer
Worldwide, nearly 400,000 cases of bladder cancer are diagnosed each year, with 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 the first- and second-line treatment of advanced bladder cancer, and the median overall survival times in these settings are approximately 12 to 15 months and 6 months, respectively. Given these short survival times and the fact that bladder cancer patients frequently develop resistance to chemotherapy, there continues to be a high unmet need for additional therapeutic options for this patient population.
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.