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Clavis Pharma announces initiation of malignant melanoma phase II clinical study


Oslo, Norway, July 6, 2007, This new phase II clinical study has recently been approved by health authorities in the Norway and Sweden and is the first clinical trial where ELACYT is used in combination with another cancer drug. The study is a multi-centre study, planned to be carried out in Europe and in the USA. Its goal is to document ELACYT’s efficacy in combination therapy with Nexavar in patients who have relapsed after treatment with other medications. Nexavar, a novel cancer drug which received marketing authorisation both in US and Europe in 2005/2006 for the treatment of patients with advanced renal cell carcinoma (kidney cancer), is currently in development for treatment of malignant melanoma. The drug is developed by Bayer Healthcare and Onyx Pharmaceuticals.

The combination study reflects Clavis Pharma’s objective to accelerate and broaden the clinical development program of ELACYT as a potential treatment of malignant melanoma. Clavis Pharma aims to achieve the following with this study;

a) position ELACYT as a combination partner

b) enhance the probability of therapeutic success by combining two anticancer agents

c) address the additional market segment of previously treated patients

It was further decided not to prolong the ongoing, open-labelled testing of ELACYT as single agent treatment in previously un-treated malignant melanoma patients. This study was initiated as a result of investigator interest and has received extensive external funding, but suffered from disappointingly low patient inclusion rates.

“Although the data from the single-treatment trial of ELACYT are still under evaluation. preliminary analysis suggest that dosing level and interval used in this trial did not achieve sufficiently strong pharmacological effect to warrant an extension of the study. We will, however, reassess ELACYT ‘s potential use as a single-agent therapy in melanoma patients when further clinical data related to dose level and intervals are available”, says Bo I. Nilsson, Chief Medical Officer of Clavis Pharma.

“The initiation of the combination therapy trial is an important extension of the development programme of ELACYT as a combinatorial drug and we have received significant interest from the scientific and clinical community regarding the trial. The decision not to prolong the exploratory trial of ELACYT as a single-agent therapy does not change our commitment to and belief that ELACYT as a potential treatment of malignant melanoma. We will focus on clinical trials that support our primary commercial strategy along the shortest path towards approval of ELACYT” said Tom E. Pike, Chief Executive Officer of Clavis Pharma.

About Metastatic Malignant Melanoma

Metastatic Melanoma is the most serious type of skin cancer. Often the first sign of melanoma is a change in the size, shape, color or feel of a mole. Each year in the United States, approximately 55,000 people are diagnosed with melanoma, and nearly 8,000 will die from the metastatic disease. Treatment of non metastatic melanoma is surgical removal whenever possible. There are at present no medical treatment options that can cure metastatic malignant melanoma, although several new drug candidates are under development in this disease.

About Clavis Pharma

Clavis Pharma ASA is a public oncology focused pharmaceutical company leveraging its proprietary Lipid Vector Technology (LVT) platform to create New Chemical Entities (NCEs) by significantly improving approved drugs. The improvement is 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 intends 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 strategic partnerships with established pharmaceutical or biotech companies. The company’s product portfolio includes three new cancer drugs, of which the first ELACYT™ , is in clinical phase II, the second, CP-4126, is in clinical phase I, and the third is in the pre-clinical phase. Results indicate that ELACYT™ has a promising potential for several cancer indications within solid tumours and leukaemia.

Clavis Pharma ASA is 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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