Clavis Pharma announces encouraging interim results of Phase II trial with elacytarabine in combination with idarubicin in patients with early stage acute myeloid lymphoma (AML)
Biomarker analysis suggests hENT1 levels may identify patients for whom elacytarabine could be an effective treatment
Oslo, Norway, 17 August 2011 -Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, announces encouraging interim efficacy data from its Phase II clinical trial with elacytarabine in combination with idarubicin in patients with acute myeloid lymphoma (AML) who have failed cytarabine (ara-C)-containing first-course chemotherapy. 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 close to 50% in patients who failed to respond to cytarabine-containing first-course treatment (11 of 23 evaluated 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.
30 patients have been assessed for hENT1 expression level at time of initial AML diagnosis before standard cytarabine treatment. Preliminary results indicate that approximately 50% of patients have low hENT1 expression. Of the patients with low hENT1, only approximately one third responded to conventional cytarabine-containing therapy, while two thirds the patients with high hENT1 responded.
The main objective of the ongoing 50-patient trial is to study response rates to the combination treatment 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.
An abstract describing these interim results has been submitted for presentation at the upcoming American Society of Haematology meeting in San Diego, CA, USA (10-13 December 2011).
Olav Hellebø, Clavis Pharma CEO, also commented: "The interim results have shown that elacytarabine in combination with idarubicin elicits a positive therapeutic effect in a substantial proportion of 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.”
*CR/CRi – complete remission including complete remission with incomplete blood count recovery.
For further information contact:
Chief Executive Officer
+47 24 11 09 50
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. CP-4126 is licensed to Clovis Oncology globally. Clavis Pharma has an option to co-promote CP-4126 in Europe.
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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.
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Mark Swallow, Ph.D.
Citigate Dewe Rogerson
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Posted: August 2011