Clavis Pharma Announces Recruitment of the First Patients in Phase II Study comparing CP-4126 with gemcitabine in pancreatic cancer

Trial will evaluate impact of patient hENT1 levels on survival outcomes Oslo, Norway, 6 August 2010 Clavis Pharma (OSE: CLAVIS), the Norwegian cancer drug development company, and its partner Clovis Oncology, Inc. announce that the first two patients have been recruited into a Phase II clinical study comparing CP-4126 (also known as CO-1.01) with gemcitabine in the treatment of patients with pancreatic cancer. The trial is being conducted by Clovis Oncology as part of the $380 million partnership agreement signed with Clavis Pharma in November 2009. Under the terms of that agreement, Clovis is responsible for development and commercialization of CP-4126 in the US, EU and certain rest of world countries. CP-4126 is a novel, patented, lipid-conjugated derivative of the anti-cancer drug gemcitabine, developed using Clavis' lipid vector technology (LVT). It is designed to improve upon the efficacy of gemcitabine by enabling the drug to enter cancer cells without requiring membrane expression of transporter proteins.  The entry of gemcitabine into tumour cells is dependent upon the expression of specific membrane transporter proteins, particularly hENT1. Gemcitabine is the current standard treatment for advanced pancreatic cancer, and is also used in combination with other chemotherapy agents for the treatment of other cancers, including ovarian, non-small cell lung and breast cancer. CP-4126 has been granted orphan drug status for the treatment of pancreatic cancer in the US and EU. The Phase II trial is an international, randomised, controlled study in patients newly diagnosed with advanced, metastatic (stage 4) pancreatic cancer. The trial will enrol approximately 250 patients, across 80 centers around the world, randomised equally between the CP-4126 and gemcitabine arms. Eligible patients will have received no prior chemotherapy for advanced disease and must have metastasis biopsies available for analysis. This is the first randomized trial in pancreatic cancer to require tumour biopsies as an entry criterion, and will allow clinical outcomes to be correlated with specific molecular features of each patient's tumour. The study will measure overall survival (OS) in prospectively-defined hENT1-low patients as the primary endpoint. Expression of hENT1 in metastatic tumour tissue will be measured during the trial and patients categorised into hENT1-high or hENT1-low groups prior to final analysis. The study is designed to show a statistically significant improvement in survival in patients with hENT1 low expression in CP-4126 compared to patients on gemcitabine. The secondary endpoints of the study include: * Overall survival in all patients and hENT1 high patients * Tumour response, progression free survival and response duration * Changes in CA 19-9, a tumour marker for pancreatic cancer * Safety and toxicity and Quality of Life Clovis Oncology anticipates that recruitment of this Phase II study will complete in 2011 and that it will report results from the trial in 2012. In parallel, Clovis Oncology has entered into an agreement with Ventana Medical Systems, Inc. for the development of a companion diagnostic test to measure hENT1-levels in pancreatic tumours and classify hENT1 low patients. Olav Hellebø, CEO of Clavis Pharma, said: "We have developed a very good working relationship with Clovis Oncology over the past six months and we have been impressed by the resources they have put behind this important study to evaluate CP-4126. We believe that new cancer therapies based on our LVT technology, such as CP-4126 and also elacytarabine, will deliver their improved efficacy by being able to reach their intended target independent of the hENT1 levels. We look forward to reporting the results from this very important study in 2012." For further information: Olav Hellebø Chief Executive Officer +47 24 11 09 50 Gunnar Manum Chief Financial Officer +47 24 11 09 71 +47 95 17 91 90 (mob) Mark Swallow / Nina Enegren / David Dible Citigate Dewe Rogerson +44 207 282 2948 About Clavis Pharma Clavis Pharma ASA is a clinical stage oncology drug development company based in Oslo, Norway with a portfolio of novel anti-cancer drugs in development. These patented New Chemical Entities (NCEs) are novel, improved versions of commercially successful drugs, made using Clavis Pharma's Lipid Vector Technology (LVT) chemistry. Data generated suggests these potential breakthrough products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue penetration, altered metabolism and, in certain cases, additional modes of action. Clavis Pharma's has several drug candidates in formal development studies: * Elacytarabine, an improved form of Ara-C, a leukaemia drug - about to commence a Phase III randomized, controlled registration study in late-stage acute myeloid leukaemia; * Intravenous CP-4126, an improved version of gemcitabine - currently in a Phase II comparative study with gemcitabine for the treatment of pancreatic cancer; * CP-4200, an azacitidine derivative - in preclinical development for myelodysplastic syndrome (MDS), often a precursor to leukaemia. Clavis Pharma intends to commercialise its products through strategic alliances and partnerships with experienced oncology businesses and, where and when commercially appropriate, by establishing its own sales and marketing capabilities. CP-4126 is licensed to Clovis Oncology in the Americas and Europe. Clavis Pharma has retained rights in other territories and an option to co-promote CP-4126 in Europe. The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS). 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. These 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 provided herein, and no claims shall be made by the recipient hereof by virtue of this News Announcement or the information contained herein. Clavis Pharma(TM) is a registered trademark of Clavis Pharma ASA. This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act) [HUG#1433728] This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction for further distribution is prohibited. Source: Clavis Pharma ASA via Thomson Reuters ONE