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Clavis Pharma ASA Clavis Pharma ASA (OSE: CLAVIS) will present results from the Phase I part of its Phase I/II study with ELACYT, within haematological cancers, at the American Society of Clinical Oncology (ASCO) Annual Meeting 2008, to be held in Chicago on 30 May to 3 June. The poster will be presented from 2:00PM to 6:00PM (CDT) on 1 June 2008 and includes updated results from all 77 patients treated in the study.
The poster will be made available on Clavis Pharma's homepage, www.clavispharma.com.
About ELACYT in haematological cancers (cancers of the blood) ELACYT is a novel cytotoxic agent, an analogue of cytarabine, a backbone of therapy in acute leukaemia. In the Phase I part of the Phase I/II study patients with haematological malignancies were treated with ELACYT as a single agent. As previously reported, patients with haematological malignancies tolerated treatment with ELACYT well at doses up to 2500 mg/m²/day both when administered as a short-lasting infusion and as continuous infusion. Clinical activity was observed with minimal non-hematologic toxicity.
The phase II part of the study is now ongoing. This phase II study is evaluating the efficacy and safety of ELACYT in patients with late stage acute myeloid leukaemia (AML). This is a patient group with limited treatment options and short expected survival. The study involves 16 major cancer centres in the USA and Europe. Based on recommendations from an international clinical expert group, patients are dosed with ELACYT 2000 mg/m2/day administered by continuous infusion.
ELACYT was granted orphan drug designation by the European Commission in September 2007 for the treatment of AML.
Gunnar Manum, CFO Office : +47 24 11 09 71 Mobile : +47 95 17 91 90 E-mail : gunnar.manum@clavispharma.com 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 three new cancer drugs, of which the first ELACYT(TM), is in Clinical Phase II, the second, CP-4126, is in Clinical Phase I, and the third, CP-4200, is in 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). Additional information on Clavis Pharma can be found at: http://www.clavispharma.com/.
About Leukaemia (cancers of the blood) Approximately 300,000 new cases of leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia represents a market with high unmet medical needs, which may open for accelerated approval processes to expedite market access for new drugs. It is a segmented market covering a broad variety of disorders. A major clinical concern is the high rate of disease recurrence. The five-year survival for the most common acute leukaemia type, acute myeloid leukaemia (AML), is in the range of 5-10% for treated elderly patients, and approximately 30% for treated younger adults.
About Orphan Drugs The European Commission grants orphan drug designation to promising products that address life-threatening medical conditions affecting fewer than 230,000 persons in the European Union (EU). The designation allows for the use of the quickest way of placing the medicinal product on the market throughout the EU (known as the "centralised procedure"), regulatory assistance related to the development process and reduced regulatory fees throughout the product's life. If a product receives marketing approval, the designation will entitle the company to exclusive marketing rights for 10 years following the approval. Orphan Drug Designation provides companies with financial and regulatory incentives to pursue less common diseases. It should be noted that orphan drug designation does not limit a drug to less common diseases. The drug may, in parallel or afterwards, also be developed for other diseases.
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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(TM) and ELACYT(TM) are registered trademarks of Clavis Pharma ASA.
