OncoGenex Completes Patient Enrollment in the Borealis-1 Trial of OGX-427
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.