Clavis Pharma Announces Successful Investigational New Drug Application Review for Intravenous CP-4126
News Jul 06, 2009
Clavis Pharma ASA announces that it has received clearance by the United States Food and Drug Administration (FDA) to include patients in the USA in its phase II clinical programme for Intravenous CP-4126.
Intravenous CP-4126 is in development as a new, first-line treatment for pancreatic cancer and the phase II programme has already been initiated in Europe. Clavis Pharma will now begin preparations at selected clinical sites for an expansion of the phase II programme into the USA.
Intravenous CP-4126 is based on Clavis Pharma’s proprietary Lipid Vector Technology (LVT) and aimed at improving the therapeutic profile of the current standard treatment for advanced pancreatic cancer, gemcitabine (Gemzar®).
Currently it is estimated that pancreatic tumors in up to two-thirds of patients have a deficient cellular uptake of gemcitabine due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the tumor cell membrane. This is known to limit the efficacy of gemcitabine treatment in these patients.
In contrast, cellular uptake of Intravenous CP-4126 is independent of hENT1, which offers a potential clinical advantage for the product in the treatment of pancreatic cancer. In the phase II programme, cancer tissue (biopsies) from each patient will be collected and analyzed with regard to levels of hENT1. The relation between response to treatment and hENT1 levels will be studied.
“Our phase II programme for Intravenous CP-4126 follows the successful completion of a phase I study in solid tumor cancer patients. This earlier trial, in line with preclinical data, suggests that CP-4126 may be of clinical benefit for patients that do not respond to gemcitabine as well as those that currently benefit from gemcitabine,” says Geir Christian Melen, CEO of Clavis Pharma.
“The acceptance of the IND is an important milestone for us that acknowledges our data on file for Intravenous CP-4126 and may enable us to accelerate our phase II programme through expansion in the USA.”