OncoGenex Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development of new therapies targeting treatment resistance in cancer patients, announced today it will begin the Cedar™ clinical trial, a randomized open-label Phase 2 trial assessing apatorsen in patients with advanced squamous cell lung cancer.
Apatorsen is an intravenous experimental drug designed to inhibit the production of heat shock protein 27 (Hsp27), an intracellular protein involved in the survival of cancer cells, leading to resistance and more aggressive cancer phenotypes. Using apatorsen alone or together with cancer treatments may increase the benefits of existing therapies or enhance the durability of treatment outcomes, ultimately leading to increased patient survival.
Close to 140 patients with previously untreated stage IV or recurrent squamous cell lung cancers or stage IIIB squamous cell cancers not responsive to radiochemotherapy, will receive either apatorsen plus gemcitabine and carboplatin therapy or gemcitabine and carboplatin alone, a chemotherapy combination commonly used to treat non-small cell lung cancer. Additionally, screenings will be preformed to determine the effect of the therapy on Hsp27 and possibly find potential biomarkers that could help predict the outcome to treatment.
The primary objective of the trial is progression-free survival with secondary objectives of tumor response rates evaluation, overall survival, safety, tolerability and health-related quality of life.
The lead investigator in this trial, Prof. Peter Schmid, MD PhD FRCP, Centre Lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, stated “despite continuing advances for the treatment of lung cancer, progress in improving survival for patients with squamous cell carcinoma has been particularly slow. 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 tochemotherapies and improve survival outcomes for patients with squamous cell lung cancer”.
With 1.6 million new cases per year, lung cancer is still the most common cancer worldwide and the leading cause of cancer death in the United States, with around 160,000 deaths in 2013 alone. The majority of all lung cancers are classified as non-small cell lung cancer, most of them metastatic or advanced at time of diagnosis. Squamous cell lung cancer accounts for 25 to 30% of all lung cancer cases reported and although for a marginal number of patients specific targeted therapy already exists, chemotherapy is still the main treatment for the majority of patients.
Cedar™ will involve around 20 centers in the United Kingdom and is an investigator-sponsored trial mainly funded by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network.