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Clavis Recruits First Patient in Pivotal Phase III Study of Elacytarabine in Late-Stage Acute Myeloid Leukaemia


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Clavis Pharma, the Norwegian cancer drug development company, announces that it has recruited the first patient into its pivotal Phase III study assessing its lead product elacytarabine in patients with late-stage acute myeloid leukemia (AML).

Elacytarabine is a novel, patented, lipid-conjugated derivative of cytarabine, the current standard treatment for AML, and is developed using Clavis' lipid vector technology (LVT). It is designed to improve upon the efficacy of cytarabine by enabling the drug to enter cancer cells without requiring membrane expression of transporter proteins. The entry of cytarabine into tumour cells is dependent upon the expression of specific membrane transporter proteins, particularly hENT1. Elacytarabine has been granted orphan drug status for the treatment of AML in the US and EU.

The Phase III study (known as the CLAVELA study) is an open-label, randomized trial comparing elacytarabine with the investigator's choice of treatment in patients with late-stage AML (i.e. those who have failed two or three previous treatment regimes). The trial will recruit up to 350 patients at 65 sites in the USA and Europe.

The primary objective of the study is to compare overall survival (OS) between patients treated with elacytarabine and those treated with the investigator's choice. The secondary objectives are to compare the response rates, duration of response, and safety profile of elacytarabine with the investigator's choice treatments. In addition, the study aims to characterize the exposure-response relationships for elacytarabine as measures of effectiveness and toxicity.

Patients randomized to the investigators' choice group can receive a range of treatments including:
• High-dose cytarabine for up to six days
• MEC - mitoxantrone, etoposide and cytarabine
• FLAG or FLAG-IDA - fludarabine, cytarabine, G-CSF and idarubicin
• Low-dose cytarabine for up to two weeks
• Hypomethylating agents - azacytidine or decitabine
• Best supportive care

The company expects to complete patient recruitment late in the second half of 2011 and to report in the second half of 2012. The results from this study, if positive, will be used by Clavis Pharma to support regulatory filings in the USA and Europe.

The Chairman of the CLAVELA study's steering committee is Professor Francis J. Giles, Professor of Medicine, Cancer Therapy & Research Center at the University of Texas Health Science Center San Antonio, USA. Prof. Giles was also Coordinating Investigator of Clavis Pharma's Phase II study with elacytarabine, which concluded in 2009 and showed a statistically significant median survival benefit of 5.3 months compared to 1.5 months in published clinical data for late-stage AML.
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