Clavis Pharma ASA : Clavis Pharma announces negative outcome of Phase III CLAVELA trial with elacytarabine in patients with acute myeloid leukaemia *Study showed no significant difference in overall survival between elacytarabine and investigator's choice of treatment in AML patients *Conference call for analysts, investors and press scheduled for tomorrow Tuesday 2 April at 10:00am CET (details below) Oslo, Norway, 1 April 2013 Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, announces results of the Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukaemia (AML). The trial showed that there was no significant difference in overall survival (OS) between the two arms where patients were randomised to receive either elacytarabine or investigator's choice of treatment. Median survival in the elacytarabine arm was 3.5 months, compared to 3.3 months in the control arm, with a hazard ratio of 0.97. Adverse events were comparable between the two arms, and no meaningful differences were observed in any subgroup analyses. All development work with elacytarabine across all indications is now suspended by Clavis Pharma. Olav Hellebø, Clavis Pharma CEO, said: "The results from CLAVELA are very disappointing for all stakeholders in Clavis and especially for AML patients for whom treatments available at this stage of their disease are few and of limited benefit. I would like to thank the patients, clinicians and all our stakeholders for their support. I would also like to thank the Clavis team for delivering a top quality global clinical trial on time and on budget. We all wish the result would have been different. "We will review the strategic options for the Company during the coming weeks, and shareholders will be informed about the alternatives available at a later date. Immediate steps will be taken to minimise our expenditure going forward, while caring for those patients who are still benefiting from elacytarabine." [CLAVELA is a 380-patient Phase III open-label randomised, controlled trial comparing elacytarabine with the investigator's choice of treatment in patients with relapsed or refractory AML. Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine, which is routinely used in the treatment of AML. The study was conducted at 76 clinical sites in the USA, Canada, Europe and Australia. The primary endpoint of the study is overall survival (OS) and the objective is to demonstrate superiority of elacytarabine over current therapies. Patients were randomised to each arm of the study and the difference in OS and other parameters, including response rates, duration of response, and safety profile of elacytarabine, was measured.] Conference call details Clavis Pharma will host a conference call at 10:00am (CET) Tuesday 2 April. Participant Access - Dial in 5-10 minutes prior to the start time using the number / Confirmation Code below: Confirmation Code: 2766414 Participants, Local - Oslo, Norway: +47 2350 0486 Participants, Local - New York: +1 646 254 3366 Participants, Local - London, United Kingdom: +44 20 3140 8286 Participants, Local - Paris, France: +33 1 70 99 42 76 Participants, Local - Munich, Germany: +49 89 1214 00699 Participants, Local - Helsinki, Finland: +35 89 6937 9543 Participants, Local - Copenhagen, Denmark: +45 32 71 16 60 Participants, Local - Stockholm, Sweden: +46 8 5051 3793 Participants, Local - Amsterdam, Netherlands: +31 20 713 2789 Participants, Local - Milan, Italy: +39 02 3626 9650 Participants, Local - Geneva, Switzerland: +41 22 567 5432 ** Contacts: Olav Hellebø Chief Executive Officer +47 24 11 09 50 email@example.com Gunnar Manum Chief Financial Officer +47 24 11 09 71 +47 95 17 91 90 (mob) firstname.lastname@example.org Mark Swallow / Nina Enegren / David Dible Citigate Dewe Rogerson +44 207 282 2948 email@example.com Peter Rahmer (US Investor enquiries) The Trout Group +1 646 378 2973 Direct / + 646 272 8526 Cell firstname.lastname@example.org About Clavis Pharma Clavis Pharma ASA is a pharmaceutical company developing novel anti-cancer drugs and companion diagnostics to identify patient populations that may benefit from treatment with these agents. Clavis Pharma is based in Oslo, Norway and listed on the Oslo Stock Exchange (ticker: CLAVIS). www.clavispharma.com Forward-looking statements This release and any materials distributed in connection with this release may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the Company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.d This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. ------------------------------------------------------------------------------ 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. Source: Clavis Pharma ASA via Thomson Reuters ONE HUG#1689291
Clavis Pharma ASA : Clavis Pharma announces negative outcome of Phase III CLAVELA trial with elacytarabine in patients with
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