Clavis Pharma ASA : Clavis Pharma announces negative outcome of Phase III CLAVELA trial with elacytarabine in patients with

  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
                        olav.hellebo@clavispharma.com

Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum@clavispharma.com

Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma@citigatedr.co.uk

Peter Rahmer (US Investor enquiries)
The Trout Group
+1 646 378 2973 Direct / + 646 272 8526 Cell
prahmer@troutgroup.com

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.

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Source: Clavis Pharma ASA via Thomson Reuters ONE
HUG#1689291
 
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