Clavis Pharma completes patient recruitment in Phase III CLAVELA study with elacytarabine in patients with acute myeloid leukaemia (AML)


Oslo, Norway, December 6, 2012

Clavis Pharma ASA (OSE: CLAVIS); the Norwegian cancer drug development company, announces that is has reached the enrolment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukaemia (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 CLAVELA study 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. The study is being 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 have been 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, will be measured. Top-line data are expected to be available in Q1 2013.

Olav Hellebø, Clavis Pharma CEO, commented: “The completion of patient recruitment for our Phase III CLAVELA study is an important achievement for Clavis Pharma and keeps us on track to report top-line efficacy data in Q1 2013. The results we have seen in the earlier Phase II trial with elacytarabine and the elacytarabine/idarubicin combination study in early stage AML patients have been encouraging, and we hope that this novel agent can become an effective new treatment option for AML patients.”

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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/+44 207 282 1050
+44 7903 737703 (mob)
clavispharma@citigatedr.co.uk

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

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About Clavis Pharma

Clavis Pharma ASA is a clinical-stage pharmaceutical company developing novel anti-cancer drugs and companion diagnostics to identify patient populations that may benefit from treatment with these agents. Clavis’ development pipeline includes novel patented versions of well-established and commercially successful drugs, made using the Company’s proprietary Lipid Vector Technology (LVT), which may offer a better efficacy /safety profile compared to the parent compounds. 

The Company’s lead product, Elacytarabine, is in a randomized, controlled Phase III study in relapsed or refractory acute myeloid leukaemia. The Company is also investigating CP-4200, an azacitidine derivative, in preclinical studies for myelodysplastic syndrome, a disease that is 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. 

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.