24. September 2004
Clavis Pharma AS announced today that it has completed a Phase I clinical study of its lead anti-cancer agent CP-4055 in patients with advanced cancer. The results demonstrate that CP-4055 may be efficacious as an anti-cancer agent and confirm its safety profile. Clavis has initiated schedule optimising studies with the aim of developing the drug as a novel cytotoxic agent for combination therapy in patients with solid tumours.
The initial Phase I clinical study involved 24 patients with advanced malignant melanoma, lung cancer or ovarian cancer who received CP-4055 as a monotherapy. CP-4055 is a novel cytotoxic drug based on Clavis' proprietary Lipid Vector Technology. The study, which was undertaken in co-operation with the Norwegian Radium Hospital, Oslo and two leading UK cancer research clinics: St Luke's Cancer Centre, Guildford, Surrey; and Princess Royal Hospital, Hull, confirmed the safety profile of the drug. Although further, more extensive studies are required, promising signs of efficacy were also reported.
'These are very promising results' commented Dr. med. Svein Dueland of the Clinical Cancer Research, Norwegian Radium Hospital, Oslo, who spearheaded the Norwegian part of the study. 'The study included patients with very advanced cancer who had failed to respond to a series of other anti-cancer agents and yet we noted some cessation of tumour growth in eight patients.'
'One of our patients with advanced non-small cell lung cancer disease, who was in progression when starting CP-4055 treatment, stabilised for 13 months with an improvement in symptoms and very little toxicity from the drug. The results are most encouraging' said Prof. Mike J Lind of the Princess Royal Hospital, Hull,UK.
'We are very excited about the prospects for CP-4055, as these preliminary results demonstrate potential efficacy at a very early stage in its clinical development' said Clavis Chairman and CEO, Mr Tom Pike. 'In the long term we intend to seek strategic partners for the further clinical development and marketing of CP-4055 to ensure its timely approval and launch. These encouraging clinical results have attracted considerable interest from a broad range of pharmaceutical companies. We are in dialogue with a number of firms, while assessing how far we should develop CP-4055 in-house.'
Clavis has initiated a follow-on clinical study in France and Belgium with the aim of determining the optimum dosing regimen for CP-4055. Further clinical studies to evaluate CP-4055 in combination with other drugs are being planned.
CP-4055 is a fatty acid derivative of cytarabine, an approved cytotoxic cancer drug. Cytarabine has limitations such as minimal uptake in solid tumours and is only used to treat leukaemia. CP-4055 is designed to overcome this limitation and has shown considerable uptake in solid tumour cells. CP-4055 is a patented new chemical entity of the nucleoside analog class, with improved biological properties and the potential to treat solid tumours such as non-small cell lung cancer, malignant melanoma and ovarian cancer. Annual global sales of cytotoxic cancer drugs are currently estimated to be US$10.5 billion. The top selling nucleoside analog drug, the same class as CP-4055, has annual sales of US$1.2 billion.
For More Information:
Clavis
Tom Pike - Chairman & CEO (+ 47) 24 11 09 50
Tom.pike@clavispharma.com
Ole Henrik Eriksen - President and COO (+47) 24 11 09 50
Ole.henrik.eriksen@clavispharma.com
Principal Investigators
Dr. med. Svein Dueland - Head of Department Clinical Cancer Research, The Norwegian Radium Hospital, Oslo, Norway (+ 47) 22 93 40 00, Svein.dueland@labmed.uio.no
Prof. Mike J Lind - Head of Academic Department of Oncology,
The Princess Royal Hospital, Hull, UK + 44 (0) 1482 67 6807 m.j.lind@hull.ac.uk
Notes to Editors
Clavis Pharma develops new and superior pharmaceuticals utilizing its proprietary Lipid Vector Technology (LVT). LVT involves the chemical binding of specific fatty acids to pharmaceutical agents, thereby creating new chemical entities with improved biological properties. LVT has the potential to improve drug performance and dosing characteristics and to open new indications for existing pharmaceuticals in a variety of therapeutic areas such as cancer and viral diseases. The technology is based on more than a decade of research conducted by Norsk Hydro, a major Norwegian industrial group. The intellectual property is protected by more than 120 internationally granted patents.
Clavis was established in 2001 by NeoMed Management and Norsk Hydro in order to commercialise new pharmaceuticals based on LVT.
Clavis' strategy is to demonstrate the efficacy of its LVT products in humans through clinical studies and then to commercialise them through strategic alliances. The company is actively seeking strategic partnerships in research and marketing.
Clavis has been financed with NOK 100 million (about US$15 million) equity capital. The lead investors are NeoMed Innovation III L.P, the UK based Medical Venture Management Ltd and Norsk Hydro. The Clavis management team has broad pharmaceutical industry experience including R&D, production, regulatory and marketing expertise.
www.clavispharma.com