OncoGenex Pharmaceuticals has started enrolment in the investigator-sponsored Rainier Phase II trial of apatorsen (OGX-427) in combination with Abraxane plus gemcitabine in patients with metastatic pancreatic cancer.
The placebo-controlled trial, sponsored by the Sarah Cannon Research Institute (SCRI), will randomise around 130 patients with either apatorsen, paclitaxel protein-bound particles for injectable suspension, or placebo in combination with Abraxane and gemcitabine therapy.
Overall survival (OS) is the primary objective of the study, which is designed to further evaluate progression-free survival (PFS), tumour response rates, safety, tolerability, and the effect of therapy on heat shock protein 27 (Hsp27) levels.
Sarah Cannon Research Institute (SCRI) GI cancer research program director Dr Johanna Bendell said median survival for patients with advanced pancreatic cancer remains low and the institute needs to explore additional strategies to address treatment resistance.
"We are very excited to open enrolment in the Rainier trial, to explore the role of Hsp27 in pancreatic cancer and to evaluate for the potential ability of apatorsen to improve clinical outcomes for patients when added to combination chemotherapy," Bendell said.
Conducted at approximately 12 sites in the US, Rainier is part of the ongoing studies evaluating treatment resistance in cancer (ORCA) programme encompassing clinical trials of apatorsen.
A once-weekly intravenous (IV) experimental drug, apatorsen is designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells' defenses and overcome treatment resistance.
Image: Micrograph of the most common type of pancreatic cancer. H&E stain. Photo: courtesy of KGH.