Clavis Pharma Announces Size of Initial hENT1-low Population in Pivotal LEAP Trial with CP-4126

Clavis Pharma ASA has announced that its partner Clovis Oncology, Inc. has been informed by the Independent Data Monitoring Committee (IDMC) for the LEAP [1] pivotal trial of CP-4126 in metastatic pancreatic cancer, that approximately 65 percent of the enrolled patients have been classified as hENT1-low.

CP-4126 (also known as CO-101) was licensed by Clovis Oncology from Clavis Pharma in 2009 in a development and commercialization agreement worth up to $585 million.

The analysis is based on 250 patients enrolled in the study through late October 2011, representing over two-thirds of the planned 360 patients expected to be enrolled in the study.

The hENT1-low patients are the target population for CP-4126, the Company’s lipid-conjugated gemcitabine.

LEAP is an international, randomized, controlled 360-patient, pivotal trial designed to demonstrate that CP-4126 improves overall survival versus gemcitabine in hENT1-low metastatic pancreatic cancer patients.

LEAP is expected to be fully enrolled at the end of the first quarter 2012 with first results expected to be reported by the end of 2012.

Olav Hellebø, Clavis Pharma CEO, said: "The information on the hENT1 status of the LEAP study population is very encouraging and confirms what we saw from the retrospective 002 study, that up to two thirds of pancreatic cancer patients are likely to be hENT1-low. This information also demonstrates that we have a sufficiently large patient population and thus a well-powered study on which to base a regulatory filing if it is positive.”