BOTHELL, Wash. and VANCOUVER, British Columbia, April 30, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Borealis-2™ clinical trial, 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 treatment.
Borealis-2 will randomize approximately 200 patients to receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone. Patients may also continue weekly OGX-427 infusions as maintenance treatment until disease progression or unacceptable toxicity if they complete all 10 planned cycles of docetaxel or are discontinued from docetaxel due to docetaxel toxicity. The primary endpoint of the trial is overall survival, with secondary objectives to evaluate safety, tolerability, tumor response rates and the effect of therapy on heat shock protein (Hsp27) levels and circulating tumor cells.
"Resistance to initial chemotherapy is a frequent occurrence in patients with advanced bladder cancer, and is often frustrating for physicians and devastating for patients who have limited treatment options available," stated Noah M. Hahn MD, Associate Professor of Medicine at Indiana University Simon Cancer Center and one of the primary investigators on the trial. "We hope that this trial will shed new light on the role of Hsp27 in bladder cancer and the ability of OGX-427 to work synergistically with second- or third-line chemotherapy to overcome resistance and prolong survival."
Borealis-2 is the second randomized, controlled clinical trial of OGX-427 in advanced bladder cancer. Borealis-1™ is 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. If either Borealis trial shows a survival advantage, OncoGenex plans to initiate conversations with the Food and Drug Administration about the possibility of a Phase 3 trial of OGX-427 in bladder cancer as part of the ORCA™ program.