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Clavis Pharma announced today that pre-clinical studies have demonstrated that Oral CP-4126 acts as a very efficient pro-drug for gemcitabine (Gemzar®).
Oral CP-4126 is a Lipid Vector Technology (LVT) derivative that can be given as tablets or capsules, and acts as a so-called pro-drug that releases gemcitabine once taken up from the gut. A recently completed study demonstrated that gemcitabine is quickly and almost completely absorbed after giving Oral CP-4126. Furthermore, the preclinical data shows a promising safety profile. The next step in the development of Oral CP-4126 will be to study the uptake and safety in cancer patients.
"These promising results obtained in our pre-clinical research have made the decision of moving Oral CP-4126 into clinical development very easy" says Geir Christian Melen, CEO of Clavis Pharma, "We are now finalising the formulation and look forward to start a clinical Phase I study".
Contacts: Geir Christian Melen, CEO Office : +47 24 11 09 65 Mobile : +47 91 30 29 65 E-mail : geir.christian.melen@clavispharma.com
Gunnar Manum, CFO Office : +47 24 11 09 71 Mobile : +47 95 17 91 90 E-mail : gunnar.manum@clavispharma.com
About Oral CP-4126 CP-4126 is a new LVT analogue of gemcitabine (Gemzar), one of the world's leading cancer drugs, used in the treatment of several cancers, such as pancreatic cancer, ovary cancer and non-small cell lung cancer. Gemzar is a blockbuster cancer drug, with sales of USD 1.6 billion in 2007, that must be given as intravenous injections. Clavis Pharma aims to develop Oral CP-4126 to provide cancer patients with the opportunity of chemotherapy taken in the form of tablets and capsules. Oral chemotherapy has many advantages, compared to intravenous administration. The most import 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 will have a different profile and potentially may 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 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, with the ticker CLAVIS. Additional information can be found at: www.clavispharma.com.
