Clavis Pharma Initiates Phase II Clinical Study Of Intravenous CP-4126 In Patients With Advanced Pancreatic Cancer

Main Category: Pancreatic Cancer
Also Included In: Clinical Trials / Drug Trials;  Cancer / Oncology
Article Date: 17 Apr 2009 - 2:00 PDT

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Clavis Pharma ASA (OSE: CLAVIS) announced initiation of the first phase II study with Intravenous CP-4126 (a novel Lipid Vector Technology analogue of gemcitabine) in patients with newly diagnosed, advanced pancreatic cancer.

The standard treatment for advanced pancreatic cancer is currently gemcitabine (Gemzar®). Unfortunately up to 2/3 of pancreatic cancers have a deficient cellular uptake of gemcitabine due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the cell membrane[1]. Cellular uptake of Intravenous CP-4126 in contrast to gemcitabine is independent of hENT1, which offers a potential clinical advantage to Intravenous CP-4126 in the treatment of pancreatic cancer.

In the phase II study, newly diagnosed untreated patients will be given Intravenous CP-4126 therapy once every week for 3 weeks, followed by one week rest. The study will investigate treatment response and overall survival. Cancer tissue (biopsies) from each patient will be collected and analysed 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 tumour 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.

Coordinating investigator Dr. Tone Ikdahl, Oslo University Hospital, Ullevål, Norway, commented: "Advanced pancreatic cancer is a very serious disease. There is an urgent need to improve the medical treatment to this patient group. The oncologists at Ullevål Cancer Centre are pleased to participate in the clinical development of Intravenous CP-4126 and look forward to start recruiting patients to this new study".

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

[1] Ref: Giovannetti et al., Cancer Research 66, 3928-3935, April 1, 2006

Source
Clavis Pharma

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