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Clovis Oncology Expands the Observational Study to Determine Patient Stratification in Pivotal LEAP Clinical Trial with CP-4126

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Clavis Pharma ASA has announced 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.

hENT1 (human Equilibrative Nucleoside Transporter) 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 randomized, 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.

Increasing recognition of the importance of hENT1 in pancreatic patients treated with gemcitabine
The use of biomarkers to target specific patient groups is of growing importance in the cancer field. In pancreatic cancer, patients with low hENT1 are of particular interest due to the low efficacy of standard gemcitabine treatment in this patient group.

New studies were presented at the recent American Society of Clinical Oncology (ASCO) annual meeting in the USA giving further evidence of the correlation between low hENT1 and poor clinical outcomes for pancreatic cancer patients treated with gemcitabine.

Most significantly, Marechal et al showed that gemcitabine provided no benefit in hENT1-low patients with resected pancreatic cancer (n=249). These findings give further evidence of the need for new therapeutic solutions for cancer patients with low levels of hENT1.

Olav Hellebø, Clavis Pharma CEO, also commented: "The body of evidence to support the relevance of the hENT1 biomarker as a basis for a companion diagnostic in pancreatic patients, where patients with low hENT1 derive little or no benefit from standard gemcitabine treatment, continues to accumulate. Clavis Pharma, together with its partners, recognizes that there is an important need for the best diagnostic possible to identify those patients with low hENT1 who could potentially derive the greatest therapeutic benefit from treatment with CP-4126.”