Clavis Pharma announces negative outcome of Phase III CLAVELA trial with elacytarabine in patients with acute myeloid leukaemia

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



Olav Hellebø

Chief Executive Officer

+47 24 11 09 50

[email protected]

Gunnar Manum

Chief Financial Officer

+47 24 11 09 71

+47 95 17 91 90 (mob)

[email protected]

Mark Swallow / Nina Enegren / David Dible

Citigate Dewe Rogerson

+44 207 282 2948

[email protected]

Peter Rahmer (US Investor enquiries)

The Trout Group

+1 646 378 2973 Direct / + 646 272 8526 Cell

[email protected]

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).

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.

Mark Swallow, Ph.D.

Citigate Dewe Rogerson

+44 (0)20 7282 2948 (direct)
+44 (0)7903 737703 (mobile)
+44 (0)20 7638 9571 (switchboard)
+44 (0)20 7282 2811 (fax)

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