Clavis Pharma's elacytarabine granted fast track designation by US FDA

Norwegian cancer drug developer Clavis Pharma (OSE: CLAVIS) says that its clinical development program with elacytarabine for the treatment of patients with acute myeloid leukemia (AML) has been granted fast track designation by the US Food and Drug Administration.

Elacytarabine is currently being evaluated in a randomized Phase III trial (known as the CLAVELA study) comparing it with the investigator's choice of treatment in patients with late-stage AML (ie, those who have failed two or three previous treatment regimes). The primary objective of the study is to compare overall survival between people treated with elacytarabine and those treated with investigator's choice. In a Phase II study, treatment with elacytarabine showed a statistically significant median survival benefit of 5.3 months compared to 1.5 months in published clinical data for late-stage AML.

The CLAVELA trial enrolled its first patient in August 2010 and aims to recruit 350 patients at 65 sites in the USA, Canada, Australia and Europe. The company expects to complete patient recruitment by the end of 2011 and to report top-line 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 USA and Europe.