OncoGenex Pharmaceuticals, Inc. has planned to initiate Rainier trial, an investigator-sponsored, randomized, placebo-controlled phase II trial evaluating OGX-427 in combination with ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer.
Rainier will randomize approximately 130 patients to receive either OGX-427 or placebo in combination with ABRAXANE and gemcitabine therapy. The primary endpoint of the trial will be overall survival, with additional analyses to evaluate progression-free survival (PFS), tumour response rates, safety, tolerability, and the effect of therapy on heat shock protein (Hsp27) levels.
"Based on the positive survival results demonstrated by the phase III MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) trial, many patients with advanced pancreatic cancer will undoubtedly receive treatment with gemcitabine plus ABRAXANE in the future. However, survival times remain short for these patients, and we need to continue to explore new strategies to address treatment resistance," stated Andrew H Ko MD, associate professor of Medicine, Division of Haematology/Oncology at the University of California, San Francisco, and a primary investigator on the trial. "The Rainier trial provides us the opportunity to explore the role of Hsp27 in pancreatic cancer, and the potential ability of OGX-427 to improve on clinical outcomes when added to combination chemotherapy."
The trial is being sponsored by the Sarah Cannon Research Institute (SCRI) and will be conducted at approximately 12 sites in the United States. Dr Andrew H Ko from the University of California, San Francisco, and Dr Johanna Bendell, director, GI Cancer Research Programme at SCRI, will serve as the primary investigators on the trial. "We are very excited to bring this trial of an exciting novel agent to patients with metastatic pancreatic cancer, who desperately need more treatment options," said Dr. Bendell.
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 II clinical trials are underway in bladder, lung, pancreatic and prostate cancers, with additional updates to the ORCA program expected to be provided later this year.
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients.
Sarah Cannon Research Institute (SCRI) is a global strategic research organization focusing on advancing therapies for patients.