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Oral anticancer drug CP-4126 enters Clinical Phase I study


Oslo, Norway, Clavis Pharma ASA announced today that its first oral anticancer drug, called Oral CP-4126, has entered Clinical Phase I. The purpose of the study is to evaluate the drug’s safety and the uptake of the active metabolite in the body.

Oral CP-4126 is a novel cancer agent for treatment of solid tumours that can be given as tablets or capsules. It acts as an efficient pro-drug, which releases its active metabolite, gemcitabine, once taken up from the gut. Preclinical studies have demonstrated that the active metabolite is quickly and almost completely absorbed into the blood stream after giving Oral CP-4126. The preclinical data also indicate a promising safety profile. Oral CP-4126 is a novel proprietary pro-drug of gemcitabine (GemzarTM), a blockbuster cancer drug that currently is only available for intravenous use.

The Clinical Phase I study will evaluate the safety of Oral CP-4126 and measure the extent of uptake of the active metabolite, gemcitabine, in the body. The dose given will be increased step-wise until the maximum tolerated dose (MTD) is reached and the dose limiting toxicity (DLT) can be established. Concentrations of the active metabolite will be measured in the blood stream of the patients. As soon as the MTD is reached, the study will continue as a controlled study comparing Oral CP-4126 to Gemzar.

“Entering clinical stage with an oral anticancer drug is a major milestone for Clavis Pharma” says Geir Christian Melen, CEO of Clavis Pharma. “With Oral CP-4126 in Clinical Phase I we are now proud to have three oncology drugs in clinical development”, he continues.

About Oral 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 2007 sales of USD 1.6 billion , that is available only as an intravenous injection. Clavis Pharma aims to develop Oral CP-4126 to provide cancer patients with the opportunity of chemotherapy taken in the form of tablets or capsules. Oral chemotherapy has several advantages, compared to intravenous administration. The most important being the potential of home treatment, which gives the patient added comfort and convenience, as well as potentially eliminating costs associated with hospitalisation.

Clavis Pharma is also 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 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™ is in Clinical Phase II, Intravenous CP-4126 is in Clinical Phase I, 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).

The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.

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.

Clavis Pharma™ and ELACYT™ are registered trademarks of Clavis Pharma ASA.


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