13 June 2006
Norway-based biopharmaceutical company Clavis Pharma ASA today announces having received regulatory clearance to initiate clinical trials with their second cancer drug CP-4126. Clavis Pharma will start a Phase I clinical trial this summer with CP-4126 for the treatment of solid tumours at the Norwegian Radium Hospital, Oslo, Norway. Two additional European cancer hospitals will be included.
CP-4126 is a novel cytotoxic agent based on Clavis Pharma's proprietary Lipid Vector Technology (LVT) which is used with the aim to create new enhanced analogues of existing drugs. The new agent has been developed to target a number of major cancer types. The objective of this first-in-man study is to determine the maximum tolerated dose of CP-4126 given as a single agent in patients with advanced solid tumours as well as elucidating the safety profile of the drug.
"CP-4126 is a patented analogue of gemcitabine (GemzarTM), a widely used cytotoxic drug approved as first line treatment in lung cancer, breast and pancreatic cancer. In pre-clinical studies CP-4126 has demonstrated a number of improved properties vs. gemcitabine which we aim to confirm in clinical trials," says Tom Pike, CEO of Clavis Pharma. "GemzarTM is a well documented anti-cancer drug with sales in the USD billion range. However, even with the most successful cancer therapies only a limited proportion of patients respond to gemcitabine and even responding tumours often become resistant to the therapy after a while. Hence, there is still an overwhelming need for improved cancer therapies such as CP-4126"
The Coordinating Investigator of the study Dr. Steinar Aamdal, MD, Professor, Department of Clinical Cancer Research, the Norwegian Radium Hospital, Oslo, Norway has previous experience with Clavis Pharma's lead candidate ELACYTTM and has seen that improvements of a parent drug with LVT has lead to promising new results. "We are excited by the opportunity to be the first centre to study CP-4126 in man and look forward to rapidly obtaining data on this new and promising drug candidate."
Contact:
Geir Christian Melen
Chief Executive Officer
Tel: +47 91302965
geir.christian.melen@clavispharma.com
www.clavispharma.com
About Clavis Pharma
Clavis PharmaTM was founded in 2001 by Norsk Hydro and NeoMed. The company develops new and superior pharmaceuticals based on its proprietary Lipid Vector Technology (LVT). LVT involves the synthesis of specific fatty acid analogues of pharmaceutical agents, thereby creating new chemical entities with improved biological properties. LVT has the potential to improve drug performance and dosing characteristics and to reduce the side effects of drug treatment for serious illnesses, such as cancer and infectious diseases. The technology is based on more than a decade of research conducted by Norsk Hydro, a major Norwegian industrial group. The intellectual property currently consists of more than 150 internationally granted patents within 5 patent families.
The company's product portfolio includes three new cancer drugs, of which the first ELACYTTM , is in clinical phase II, the second CP-4126, is entering clinical phase I, and the third is in the pre-clinical phase. Research results so far indicate that ELACYTTM has a promising potential for several cancer indications within solid tumours and leukaemia.
Clavis Pharma's largest investors are: MVM Fund, NeoMed Innovation III, Norsk Hydro, Braganza AS and Techinvest II DA (Høegh).
Additional information on Clavis Pharma can be found at: www.clavispharma.com
About the global cancer market
Globally, more than 10 million people are diagnosed with cancer every year and cancer rates could further increase by 50% to 15 million new cases per year in 2020, according to the World Cancer Report. Cancer causes 6 million deaths annually, representing 12% of deaths worldwide. According to Business Insights the global cancer market was valued at USD 47.5bn in 2005, which was an increase of 16.1% from 2004. This makes the sector the strongest growing component of the global pharmaceutical market. Although the mean survival rates for cancer patients have increased over the past 25 years, there is still an overwhelming unmet clinical need in most cancer types.
Disclaimer
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and
depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations
and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments
to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other
things, risks associated with technological development, the risk that research & development will not yield new products
that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the
risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
No expressed or implied representations or warranties are given concerning Clavis Pharma or the accuracy or completeness of the information or projections provided herein, and no claims shall be made by the recipient hereof by virtue of this Information Memorandum or the information or projections contained herein. Any representations or warranties made to an investor in Clavis Pharma will be subject to separate sale and purchase agreements to be negotiated between the parties.