OncoGenex Pharmaceuticals Inc. announced initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer. Apatorsen is a once-weekly intravenous (IV) experimental drug that is designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells’ defenses and overcome treatment resistance.
Approximately 140 patients with previously untreated Stage IV or recurrent squamous cell lung cancers or Stage IIIB squamous cell cancers that are not amenable to radiochemotherapy will be randomized to receive either apatorsen plus gemcitabine and carboplatin therapy, or gemcitabine and carboplatin therapy alone. The primary objective is progression-free survival (PFS), with secondary objectives to evaluate tumor response rates, overall survival, safety, tolerability, and health-related quality of life. Additional analyses will be conducted to determine the effect of therapy on Hsp27 levels and to explore potential biomarkers that may help predict response to treatment.
“Despite continuing advances for the treatment of lung cancer, progress in improving survival for patients with squamous cell carcinoma has been particularly slow,” said Professor Peter Schmid, center lead, Center for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London and the primary investigator on the trial. “Given the depth of preclinical evidence supporting the utility of apatorsen in a broad range of cancers, we are excited to open enrollment in the Cedar trial to shed greater light on the ability of apatorsen to reduce resistance to chemotherapies and improve survival outcomes for patients with squamous cell lung cancer.”
Cedar is an investigator-sponsored trial being conducted and funded primarily by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and will involve approximately 20 centers in the United Kingdom.
Date: July 1, 2014