OncoGenex Pharmaceuticals plans initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label phase II trial evaluating OGX-427 in previously untreated patients with advanced squamous cell lung cancer.

This trial will be the seventh randomized phase II clinical trial evaluating OGX-427 in the treatment of advanced cancers and will investigate whether adding OGX-427 to gemcitabine and carboplatin therapy can extend progression-free survival (PFS) outcomes. OGX-427 is a once-weekly intravenous (IV) drug  designed to inhibit production of heat shock protein (Hsp27) to disable cancer cells' defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes.

Cedar will randomize approximately 140 patients to receive either OGX-427 plus gemcitabine and carboplatin therapy or gemcitabine and carboplatin therapy alone. The primary objective will be 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.

"Given the preclinical evidence demonstrating significant overexpression of Hsp27 in squamous cell lung cancers, the ability of OGX-427 to inhibit the production of this protein that is linked with resistance to chemotherapy, and the viable combination with gemcitabine and carboplatin, we are hopeful that Cedar will provide meaningful data on the potential of OGX-427 to improve survival outcomes in this difficult-to-treat population," said Professor Peter Schmid, M.D., Ph.D., FRCP, director of the Barts/Brighton Experimental Cancer Medicine Centre and the primary investigator on the trial.

The trial is being conducted by the U.K. National Cancer Research Network and the U.K. Experimental Cancer Medicine Network and will involve 35 centers in the U.K.

Cedar will be the second randomized phase II trial of OGX-427 in advanced lung cancer. OncoGenex plans to initiate the Spruce trial, an investigator-sponsored, randomized, placebo-controlled phase II trial evaluating OGX-427 in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung cancer. Spruce is being conducted in partnership with the Sarah Cannon Research Institute and is expected to begin enrollment later this year.