Oslo, 19 February 2003
Clavis Pharma AS (formerly ConPharma As) today announced that its most advanced compound, CP-4055, has entered Phase I/II clinical trials for the treatment of slid tumours at cancer research clinics in the UK and Norway.
To date, four patients have received CP-4055 and the study has now moved onto the second dose level. The Phase I trial will enrol patients with non small-cell lung cancer, ovarian cancer and malignant melanomas. The primary objectives of this dose escalating study are to define the Maximum Tolerated Dose (MTD) level and the Dose Limiting Toxicity (DLT). The secondary objectives are to show efficacy and to evaluate pharmacokinetics. The study is expected to be completed in Q4 2003.
CP-4055 is a novel cytotoxic agent based on Clavis Pharma's proprietary Lipid Vector Technology (LVT). The new agent has been developed to target solid tumours such as non-small cell lung cancer, malignant melanoma, ovarian cancer, colon cancer and potentially also haematological cancer. The global oncology treatment market is currently estimated to be worth $20 billion.
Ole Henrik Eriksen, Chief Executive Officer, Clavis Pharma commented 'This is an important landmark for the company as our first compound enters the clinic. Clavis' proprietary Lipid Vector Technology enhances drug performance and can open up new indications for a broad range of existing therapies. Positive results from these trials will validate the safety and efficacy of LVT-based therapeutics'.
CP-4055 has been extensively tested in different human xenograft models and has successfully completed safety pharmacology and toxicology testing. CP-4055 has a unique mechanism for cellular uptake such that sustained cellular levels of the active agent can be achieved. It has demonstrated superior efficacy compared to other cytotoxic agents and complete tumour suppression has been satisfactorily demonstrated in several models.
For further information, please contact:
Ole Henrik Eriksen
President & CEO
Clavis Pharma AS
+ 47 24 11 09 50
+47 24 11 09 51 (fax)
ole.henrik.eriksen@clavispharma.com
www.clavispharma.com
About Clavis Pharma AS
Clavis Pharma was originally established as ConPharma in August 2001 to develop new and improved 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 such as increased cellular uptake, reduced
toxicity and slow release of the active compound. The company has demonstrated that the LVT has the potential to improve drug
performance and to open new indications for existing pharmaceuticals in a variety of therapeutic areas such as cancer and
viral diseases.The company is underpinned by more than a decade of LVT research conducted by Norsk Hydro, Norway's largest
chemical corporation. The complete intellectual property and patent portfolio in this field has been transferred to Clavis
Pharma, and the company has A strong intellectual property portfolio including 6 US patents and more than 100 internationally
granted patents.
Clavis Pharma's strategy is to demonstrate the efficacy of its LVT products in humans through clinical studies and commercialise
them through strategic alliances. The company is actively seeking strategic partnerships in research and marketing.
Clavis Pharma was initially financed with equity capital from Norsk Hydro and NeoMed Innovation III L.P. A second round of
financing of NOK 80 Mill was successfully closed in July 2002 funding the clinical development of the CP-4055 and preclinical
development of Clavis Pharma's second candidate addressing key cancer indications. The lead investor in the second financing
was the UK based Medical Venture Management Ltd.
Clavis Pharma has an experienced management team including members who have successfully taken pharmaceuticals to the international
market. The company has a wide international network OF research, development and manufacturing contacts. The Board of Clavis
Pharma consists of people with experience from the international pharmaceutical and healthcare venture capital industry.
www.clavispharma.com