Clovis Expands CP-4126 Trial - Drug Discovery and Development

Clavis Pharma ASA, the Norwegian cancer drug development company, announces that Clovis Oncology, Inc, its development partner for CP-4126, has expanded the ongoing observational study to determine the patient stratification parameters in the pivotal LEAP clinical trial with CP-4126.

CP-4126 is a new, patented, lipid-conjugated form of the anti-cancer compound gemcitabine developed by Clavis Pharma using its lipid vector technology. It is currently being investigated in a pivotal clinical study (known as LEAP) in patients with newly diagnosed metastatic pancreatic cancer; the primary end point is overall survival in low hENT1 patients receiving CP-4126 compared to gemcitabine. This study is being conducted by Clovis Oncology.

Low hENT1 levels have been correlated to poor clinical outcome of gemcitabine treatment, the standard treatment for many solid tumours (see below). hENT1 (human Equilibrative Nucleoside Transporter 1) is a protein expressed on the surface of certain cancer cells that has been shown to be important for the uptake and efficacy of gemcitabine.

In 2Q 2011, Clovis Oncology initiated an observational analysis (study 002) of hENT1 expression in pancreatic cancer patients using a biomarker assay to define the criteria for low and high hENT1 levels as part of the CP-4126 programme. The criteria for a cut-off for low hENT1 levels will be established using randomised, controlled cancer tissue samples from patients with known disease outcome, and who have been treated with gemcitabine or 5-FU. Patients enrolled in the LEAP study will be prospectively stratified as hENT1-high or hENT-low based on the outcome of this analysis and before clinical data from the trial are known.

Since the initiation of the observational study, Clovis Oncology has developed a second, improved hENT1 biomarker assay, which is currently being validated. Therefore, the results of the analysis, which were due in 1H 2011, are now anticipated in 2H 2011 such that the hENT1 cut-off to be used to stratify patients in clinical trials investigating CP-4126 is expected to be established by 4Q 2011.

Date: June 29, 2011
Source: Clavis Pharma ASA