Clavis Pharma initiates Phase II pancreatic cancer trial

Norway-based pharmaceutical company Clavis Pharma has initiated the first Phase II study with Intravenous CP-4126 in patients with newly diagnosed, advanced pancreatic cancer.

Intravenous CP-4126 is a novel lipid vector technology analogue of gemcitabine. In the Phase II study, newly diagnosed untreated patients will be given Intravenous CP-4126 therapy once every week for three weeks, followed by one week rest. The study will investigate treatment response and overall survival. Cancer tissue from each patient will be collected and analyzed with regard to levels of hENT1. The relation between efficacy and hENT1 levels will be studied.

The Intravenous CP-4126 Phase II study follows the successful completion of a Phase I study in solid tumor cancer patients. The Phase I results are encouraging, showing that administration of Intravenous CP-4126 provided a prolonged presence of the therapeutically active agents in the blood.

In line with preclinical data, the Phase I results suggest that the drug may be of clinical benefit for patients that do not respond to gemcitabine as well as for patients that currently benefit from gemcitabine.

Christian Melen, CEO of Clavis Pharma, said: Intravenous CP-4126 may prove to provide clinical benefit to a larger group of pancreatic cancer patients than gemcitabine. We are very pleased to now enter Phase II with Intravenous CP-4126, which is our second product in clinical Phase II development.