Oslo, Norway, 16 April 2009
Clavis Pharma ASA (OSE: CLAVIS) announced today 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 membrane1. 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
Contact:
Geir Christian Melen
Chief Executive Officer
Office : +47 24 11 09 50
Mobile : +47 91 30 29 65
E-mail :
geir.christian.melen@clavispharma.com
Gunnar Manum
Chief Financial Officer
Office : +47 24 11 09 71
Mobile : +47 95 17 91 90
E-mail :
gunnar.manum@clavispharma.com
About Intravenous CP-4126
CP-4126 is a novel Lipid Vector Technology analogue of gemcitabine (Gemzar®), one of the world's leading cancer drugs, used
in the treatment of several cancers, such as pancreatic cancer, ovarian cancer and non-small cell lung cancer. Gemzar is a
blockbuster cancer drug, with 2008 sales of USD 1.7 billion . Clavis Pharma is developing Intravenous CP-4126, which has a
different therapeutic profile and may potentially have effect in patients who are resistant or refractory to gemcitabine treatment.
About Pancreatic cancer
Pancreatic cancer is a very serious disease and an indication with an unmet medical need. Approximately 37,000 new cases of
pancreatic cancer were recorded in the USA in 2007. The 1-year and 5-year overall survival rates are estimated at 23% and
4%, respectively. The majority of these patients have unresectable disease or will recur after surgery. Median overall survival
in these patients is approximately 8-12 months. The standard first-line therapy for patients with unresectable disease is
gemcitabine monotherapy. Unfortunately, many of these patients fail to benefit from treatment.
About Clavis Pharma
Clavis Pharma ASA is an oncology focused pharmaceutical company using its proprietary Lipid Vector Technology (LVT) platform
to create New Chemical Entities (NCEs), by significantly improving already established drugs. The improvements are achieved
by chemically binding specific unsaturated lipids to existing, and well understood, approved pharmaceuticals. Data generated
suggests the resulting patentable NCEs offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties,
greater tissue penetration and, in many cases, additional modes of action.
Clavis Pharma's objective is to develop its drug candidates until significant value has been created and proof of principle in man has been shown. For further clinical development and commercialisation of the products, Clavis Pharma will enter into strategic partnerships with established pharmaceutical or biotech companies. The company's product portfolio includes four new cancer drugs: Elacytarabine [pINN] and Intravenous CP-4126 are in Clinical Phase II, Oral CP-4126 in Phase I, and CP-4200 is in early preclinical development. Results indicate that these products have promising potential for several cancer indications within solid tumours and leukaemia.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS).
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