Borealis-2 Clinical Trial Evaluating OGX-427 In Combination With Second-Line Therapy For Bladder Cancer Announced

Main Category: Clinical Trials / Drug Trials
Also Included In: Cancer / Oncology
Article Date: 13 Feb 2013 - 4:00 PST


OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) has announced plans for the initiation of the Borealis-2 clinical trial, an investigator-sponsored, randomized, controlled Phase 2 study evaluating OGX-427 in patients with advanced or metastatic bladder cancer who have disease progression following initial platinum-based chemotherapy treatment. The trial, which is the fourth Phase 2 study of OGX-427 in a genitourinary (GU) cancer, will investigate if combining OGX-427 with docetaxel, a standard option in salvage treatment for metastatic bladder cancer, improves survival compared to docetaxel alone.

"Bladder cancer is often sensitive to chemotherapy in the first-line setting, but, when patients relapse, resistance to chemotherapy is frequent," stated Jonathan Rosenberg MD, Associate Physician, Memorial Sloan-Kettering Cancer Center and one of the primary investigators on the study. "This trial will evaluate the potential of OGX-427 to work synergistically with second- or third-line chemotherapy to overcome treatment resistance and prolong survival in patients with advanced bladder cancer."

Limited options exist for both the first- and second-line treatment of advanced bladder cancer. Currently, first-line platinum-based chemotherapy regimens result in a median overall survival of approximately 12-15 months. Docetaxel is commonly used in second-line treatment, with a reported median overall survival of approximately six months. Given acquired treatment resistance and these short survival times, there continues to be a high unmet need for additional therapeutic options for this patient population.

OGX-427 is designed to inhibit Heat Shock Protein 27 (HSP27), a cell-survival protein found at elevated levels in many human cancers including prostate, bladder, breast and non-small cell lung cancer. Overexpression of Hsp27 is thought to be an important factor leading to the development of treatment resistance and is associated with negative clinical outcomes in patients with various tumor types.

"The launch of Borealis-2 marks OncoGenex' continued commitment to expanding the OGX-427 clinical development program to better understand treatment resistance in GU cancers," said Scott Cormack, President and Chief Executive Officer of OncoGenex. "Given the growing incidence of bladder cancer due to an aging population, we believe there is an urgent need to identify new strategies to address treatment resistance and potentially improve outcomes in this patient population."

Borealis-2 will be the second randomized, controlled clinical trial of OGX-427 in advanced bladder cancer. The Borealis-1 clinical trial is the OncoGenex-sponsored, randomized, placebo-controlled Phase 2 study designed to evaluate a potential survival benefit, safety and tolerability of combining OGX-427 with gemcitabine and cisplatin in the first-line treatment of patients with advanced 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 study of OGX-427 in bladder cancer as part of the ORCA program.

About Borealis-2

The Borealis-2 clinical trial 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 objective will be overall survival, with secondary objectives evaluating safety, tolerability, tumor response rates and the effect of therapy on Hsp27 levels and circulating tumor cells.

Borealis-2 will be conducted at approximately 30 sites in the U.S. and is being sponsored by the Hoosier Oncology Group. Dr. Noah Hahn from the Indiana University Simon Cancer Center, Dr. Toni Choueiri from the Dana-Farber Cancer Institute and Dr. Jonathan Rosenberg from Memorial Sloan-Kettering Cancer Center will serve as the primary investigators on the study.

ABOUT ORCA

The "ORCA" (Overcoming Resistance in CAncer) program encompasses the on-going studies of OGX-427 aiming to demonstrate that inhibition of Hsp27 can lead to improved prognosis and treatment outcomes for cancer patients. Phase 2 clinical trials are underway in prostate and bladder cancers, with additional studies expected to initiate this year. For more information on OGX-427 and ORCA, please visit http://www.OncoGenex.com.

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