Elacytarabine in combination with idarubicin shows promising efficacy in Phase II trial in patients with early stage acute myeloid leukaemia (AML)


Data presented at the American Society of Hematology annual meeting

Oslo, Norway, 10 December 2012

Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, announces data from its Phase II clinical trial with elacytarabine in combination with idarubicin. The trial enrolled patients with early stage acute myeloid leukaemia (AML), for whom cytarabine-containing first-course chemotherapy has failed and results were presented* by Dr David Rizzieri from Duke University Medical Center yesterday at the American Society of Haematology annual meeting in Atlanta, GA. Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine, which is routinely used in the treatment of AML.

The results found that treatment with the elacytarabine/idarubicin combination showed promising clinical activity with a complete remission (CR/CRi**) rate of approximately 43% in patients who failed to respond to first-course treatment (20 of 46 evaluable patients). To date, 13 patients were deemed fit enough following treatment to be referred for stem cell transplantation, which represents a potential cure for these patients. The safety profile is consistent with this type of cytotoxic therapies.

The main objective of the 51-patient trial is to demonstrate that patients failing cytarabine can be rescued by elacytarabine. The study was conducted at leading haematology clinics in the USA and Europe.

Olav Hellebø, Clavis Pharma CEO, commented: "The results have shown that elacytarabine in combination with idarubicin elicits a therapeutic effect in a substantial proportion of early stage AML patients for whom first-course cytarabine treatment failed. This is very encouraging and highlights the potential of elacytarabine to offer a new treatment option to patients who may not respond to current standard cytarabine-containing therapies. We would like to thank the investigators and their patients for taking part in this study.”

About the Phase II study
Fifty one adult patients with AML who have not attained complete remission after the first induction course with a standard-dose cytarabine-anthracycline based regimen were enrolled in the study. Patients received a combination of elacytarabine and idarubicin, as second induction course at a dose of 1000 mg/m2/day continuous infusion of elacytarabine on days 1–5 in combination with idarubicin at 12 mg/m2/day IV days 1–3. Patients treated with further courses received either the combination therapy or elacytarabine monotherapy at 2000 mg/m2/day on days 1–5, at the investigator`s discretion.

* Abstract #46: “A Phase II Study of Elacytarabine/Idarubicin as Second Course Remission-Induction in Patients with Acute Myeloid Leukemia who Failed Cytarabine/Anthracycline.” The presentation is available to download from www.clavispharma.com .

**CR/CRi – complete remission including complete remission with incomplete blood count recovery                                                    

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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 (the CLAVELA study) that recently completed recruitment 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.