OncoGenex Pharmaceuticals, Inc., a biopharmaceutical company,has planned to initiate 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.
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 tumour response rates, overall survival, safety, tolerability, and health-related quality of life. Additional analyses will be conducted to determine the effect of therapy on heat shock protein 27 (Hsp27) levels and to explore potential biomarkers that may help predict response to treatment.
"Despite recent advances for the treatment of lung cancer, limited progress has been made to improve survival outcomes for patients with squamous cell carcinoma," stated Prof. Peter Schmid MD PhD FRCP, director of the Barts/Brighton Experimental Cancer Medicine Centre and the primary investigator on the trial. "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."
The trial is being conducted by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and will involve 35 centres in the UK.
Cedar will be the second randomized phase II trial of OGX-427 in advanced lung cancer. OncoGenex also recently announced 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 (NSCLC). Spruce is being conducted in partnership with the Sarah Cannon Research Institute (SCRI) and is expected to begin enrollment later this year.
Lung cancer is the most common cancer worldwide and is the leading cause of cancer death among both men and women in the United States. About 80 per cent of all lung cancers are identified as non-small cell lung cancer (NSCLC), and a majority of these are metastatic, or advanced, at diagnosis. Non-squamous histology NSCLC includes adenocarcinoma and large cell carcinoma, and accounts for more than half of all diagnoses. Squamous histology NSCLC accounts for about 25 to 30 per cent of all lung cancer cases. Although specific targeted therapy has been identified for a minority of patients, chemotherapy remains the backbone of treatment for the majority of patients with lung cancer.
OGX-427 is a once-weekly intravenous (IV) drug that is 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.
The ORCA (Ongoing Studies Evaluating Treatment Resistance in CAncer) programme encompasses clinical trials of OGX-427. Phase 2 clinical trials are underway in bladder, lung, pancreatic and prostate cancers.
OncoGenex is committed to the development and commercialization of new therapies that address treatment resistance in cancer patients.