Leukaemia treatment gains fast track designation

Clavis Pharma’s elacytarabine currently in Phase III trial

Clavis Pharma, a Norwegian cancer drug development company, reports that its clinical development programme with elacytarabine for the treatment of patients with acute myeloid leukaemia (AML) has been granted fast track designation by the US Food & Drug Administration (FDA).

Elacytarabine is currently being evaluated in a randomised Phase III trial (known as the Clavela study) comparing it with the investigator's choice of treatment in patients with late-stage AML. The primary aim of the study is to compare overall survival between patients treated with elacytarabine and those treated with the investigator's choice.

In a Phase II study, treatment with elacytarabine showed an average survival benefit of 5.3 months compared with 1.5 months in published clinical data for late-stage AML.

The Clavela trial enrolled its first patient in August this year and aims to recruit 350 patients at 65 sites in the US, Canada, Australia and Europe. The company expects to complete patient recruitment by the end of 2011 and to report results 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 US and Europe.

Olav Hellebø, chief executive of Clavis Pharma, said: ‘We are pleased to have been granted fast track designation from the FDA for our elacytarabine programme, alongside the orphan drug designation granted previously. It confirms that there is a significant need for a new treatment for AML given the proportion of patients who do not respond to standard cytarabine treatment or who become less responsive over the course of such treatment.’