OncoGenex Pharmaceuticals, Inc. OGXI today 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.
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