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Promising interim results of Phase II trial with elacytarabine in combination with idarubicin in patients with early stage acute myeloid leukaemia (AML) presented at ASH annual meeting

December 12, 2011 - London

Oslo, Norway. 12 December 2011

Clavis Pharma ASA (OSE: CLAVIS) announces that promising interim efficacy data from its Phase II clinical trial with elacytarabine in combination with idarubicin in patients with early stage acute myeloid leukaemia (AML) who have failed cytarabine-containing first-course chemotherapy were presented* on Saturday 10 December at the American Society of Haematology annual meeting (San Diego, CA, USA). Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine created by Clavis Pharma using its Lipid Vector Technology (LVT).

The interim results found that treatment with the elacytarabine/idarubicin combination showed promising clinical activity with a complete remission (CR/CRi**) rate of approximately 46% in patients who failed to respond to cytarabine-containing first-course treatment (12 of 26 evaluable patients). To date, nine patients were deemed fit enough following treatment to be referred for stem cell transplantation, which represents a potential cure for these patients.

As expected, these responses are independent of the patient's hENT1 status. hENT1 (human Equilibrative Nucleoside Transporter 1) is a protein expressed on the surface of cancer cells that has been shown to be important for the uptake and efficacy of cytarabine.

Separately 30 patients were assessed for hENT1 expression level at time of initial AML diagnosis before standard cytarabine containing treatment. Preliminary results indicate that approximately 50% of patients have low hENT1 expression (defined as less than 10% of cancer cells stained). Of the patients with low hENT1, only approximately one third responded to conventional cytarabine-containing first-line therapy, while two thirds of patients with high hENT1 responded.

The main objective of the ongoing 50-patient trial is to study response rates to elacytarabine combination treatment after cytarabine combination treatment has failed and the relationship of outcome to the patient's hENT1 status. The study is being conducted at leading haematology clinics in the USA and Europe and top-line results are expected to read out in Q3 2012.

Olav Hellebø, Clavis Pharma CEO, commented: "The interim results have shown that elacytarabine in combination with idarubicin elicits a positive therapeutic effect in a substantial proportion of early stage AML patients for whom first-course cytarabine treatment failed. This is very encouraging and, with the hENT1 data seen, highlights the potential of our LVT drugs to offer an effective treatment option to patients who may not respond to current standard cancer therapies."

* Abstract #42825: "A Phase II Study of Elacytarabine/ Idarubicin as Second Course Remission-Induction in Patients with Acute Myeloid Leukemia who Failed Cytarabine/Anthracycline, and Evaluation of the Impact of the Nucleoside Transporter hENT1 on Response. The poster is available to download from

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

For further information contact:

Olav Hellebø
Chief Executive Officer
+47 24 11 09 50

Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)

Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948

About Clavis Pharma
Clavis Pharma ASA is a late clinical stage oncology discovery and drug development company based in Oslo, Norway with a portfolio of novel anti-cancer drugs in development. These patented New Chemical Entities (NCEs) are novel, improved versions of commercially successful drugs, made using Clavis Pharma's Lipid Vector Technology (LVT) chemistry. Data generated suggests these potential breakthrough products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue penetration, altered metabolism and, in certain cases, additional modes of action.

Clavis Pharma's has several drug candidates in formal development studies:

  • Elacytarabine, a leukaemia drug, currently in a randomized, controlled Phase III study in late-stage acute myeloid leukaemia;
  • CP-4126, is currently in a pivotal clinical study compared to gemcitabine for the 1st line treatment of pancreatic cancer and a Phase II trial for 2nd line treatment for pancreatic cancer in patients refractory to 1st line gemcitabine treatment;
  • CP-4200, an azacitidine derivative, in preclinical development for myelodysplastic syndrome (MDS), 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. 

The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.

This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

No expressed or implied representations or warranties are given concerning Clavis Pharma or the accuracy or completeness of the information or projections provided herein, and no claims shall be made by the recipient hereof by virtue of the information or projections contained herein. Clavis Pharma is a registered trademark of Clavis Pharma ASA.

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



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