Clovis Oncology has completed patient enrolment in its pivotal Low hENT1 and Adenocarcinoma of the Pancreas (LEAP) study of CO-101 versus gemcitabine in metastatic pancreatic cancer patients.
CO-101, also known as CP-4126, is a patented, lipid-conjugated form of the anti-cancer drug gemcitabine, which was designed to enter cancer cells regardless of human Equilibrative Nucleoside Transporter 1 (hENT1) expression.
CO-101 is intended to address the unmet need of patients with pancreatic cancer whose tumours express low amounts of hENT1 and are therefore expected to be resistant to standard gemcitabine therapy.
LEAP is an international randomised controlled 360-patient pivotal trial, in which patients are being randomised on a one-to-one basis to receive either CO-101 or gemcitabine.
The study is being conducted at 99 centres in 15 countries to demonstrate that CO-101 improves overall survival compared to gemcitabine in hENT1-low metastatic pancreatic cancer patients.
Clovis Oncology president and CEO Patrick Mahaffy said the trial has the potential to be practice-changing in the management and treatment of metastatic pancreatic cancer for which only limited options are available.
LEAP is the first trial that seeks to prospectively demonstrate the correlation using a fully validated IHC assay, with a pre-defined 'cut-off' of hENT1-high and hENT1-low, the company said.
CO-101 has already received an orphan drug designation in the US and European Union for the treatment of pancreatic cancer.
The company plans to file for approval in the US and European Union by mid 2013, if the trial is successful.
Headquartered in Boulder, US, Clovis Oncology is a biopharmaceutical company focused on acquiring, developing and commercialising innovative anti-cancer agents in the US, Europe and additional international markets.
Image: Micrograph of pancreatic ductal adenocarcinoma. Photo: KGH.