Promising Clinical Phase I results for Intravenous CP-4126 presented at ESMO
Oslo, Norway, September 15, 2008-Clavis Pharma ASA (OSE: CLAVIS) announced today that promising results from its Intravenous CP-4126 Phase I study in patients with solid tumours have been presented at the European Society for Medical Oncology (ESMO) Meeting 2008. The presentation was held on 13 September.
Intravenous CP-4126 is a novel anticancer agent designed to circumvent important drug resistance mechanisms. Clinical Phase I is almost completed and based on the encouraging safety and the pharmacokinetic data obtained, Phase II studies are being planned in cancer indications where Intravenous CP-4126 has the potential to show better efficacy than current therapy.
The key results presented at ESMO:
- Intravenous CP-4126 provides prolonged presence of the therapeutically active agents in the blood plasma. CP-4126 itself was detected for 24 hours at concentrations known to stop cancer cell growth.
- The primary metabolite of CP-4126 - gemcitabine - was detected in plasma at similar or higher levels and for a longer duration than reported after injection of therapeutic doses of gemcitabine itself.
- The most frequent toxicities observed were as expected for this type of cancer therapeutics.
In the Phase I dose-finding study, Intravenous CP-4126 was given at doses from 30 to 1600 mg/m2/day to 32 patients with different solid tumour indications. The maximum tolerated dose was determined at 1600 mg/m2/day, when administered as a 30 minutes infusion on days 1, 8 and 15 in a 4 week schedule. Patient enrolment is ongoing on 1400 mg/m2/day to establish the recommended Phase II dose. The dose limiting toxicities were reversible elevation of liver enzymes and myelosuppression (neutropenia). The most commonly related adverse events were nausea, vomiting, fatigue and anorexia and the majority of these were of mild degree.
About Intravenous CP-4126
Intravenous CP-4126 is a new analogue of gemcitabine (Gemzar(TM)), 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 sales of USD 1.6 billion in 2007, that must be given as intravenous injections. Clavis Pharma has developed Intravenous CP-4126 based on its proprietary Lipid Vector Technology (LVT) to improve uptake into cancer cells and to prolong the retention of the active metabolite inside the cells. CP-4126 is independent of a certain cellular uptake mechanism (a specific nucleoside transporter) which the parent drug gemcitabine is dependent of for entry into the cell. Patients have various expression levels of this specific uptake mechanism and the level is known to play an important role in the outcome of gemcitabine treatment of pancreatic cancer and lung cancer patients.
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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: ELACYT(TM) is in Clinical Phase II, Intravenous CP-4126 is in Clinical Phase I, Oral CP-4126 is in late preclinical development 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). Additional information on Clavis Pharma can be found at: http://www.clavispharma.com/.
Posted: September 2008