OncoGenex meets target enrollment in apatorsen Phase 2 trial

Sep 30 2015

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-1^TM 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."