BOTHELL, Wash. and VANCOUVER, British Columbia, July 10, 2012 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today an update on the clinical development program for custirsen and details on plans to initiate a Phase 3 clinical trial in non-small cell lung cancer (NSCLC).The trial, planned to begin enrollment later this year, will evaluate the potential survival benefit of combining custirsen with docetaxel, a standard second-line chemotherapy treatment used in patients who have progressed after initial, or first-line, treatment has failed.
The Phase 3 trial will be an international, randomized, open-label study that will enroll approximately 1,100 patients with advanced or metastatic NSCLC who have been previously treated with a first-line platinum-based chemotherapy. Patients will be randomized to receive custirsen plus docetaxel or docetaxel alone. The primary objective of the study will be overall survival with additional secondary and exploratory analyses of other efficacy outcomes and biomarker relationships. Two formal interim analyses are planned for stopping the trial early based on inadequate evidence of clinical benefit or futility. No interim analyses for claiming efficacy are planned.
Custirsen is designed to block production of clusterin, a cell survival protein that is commonly overexpressed in several cancer types and in response to anticancer treatments. Phase 2 data from a single-arm study evaluating custirsen in combination with a gemcitabine/platinum-based regimen in first-line NSCLC were published earlier this year. The data demonstrated a median overall survival of 14.1 months, decreased serum clusterin levels in 95% of patients evaluated, with lower serum clusterin levels during study treatment correlating to longer survival outcomes, and a toxicity profile not felt to be appreciably different than those reported for previously published similar combinations.
"We are pleased that we and Teva have identified a clear path forward to evaluate custirsen in patients who are suffering from this terrible disease," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "In previous studies in prostate and other cancers, custirsen has been shown to work synergistically with docetaxel, a globally accepted standard of care in advanced lung cancer. We are excited about the initiation of this trial and its potential to improve outcomes for patients."In addition to the planned Phase 3 study in NSCLC, custirsen, in combination with chemotherapy, is currently being evaluated in Phase 3 trials for patients with castrate-resistant prostate cancer (CRPC). Custirsen has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treatment of patients with CRPC receiving first-line docetaxel chemotherapy.
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