OncoGenex Pharmaceuticals has completed enrollment in Borealis-1, a company-sponsored, randomized, placebo-controlled phase II 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 (600mg or 1000mg) v. 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," said Cindy Jacobs M.D., Ph.D., 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 FDA 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 II 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 is enrolling patients.