FDA Grants Fast Track Designation for Clavis Leukaemia Drug

22 December 2010 (Last Updated December 22nd, 2010 18:30)

Clavis Pharma ASA has been granted fast-track designation by the US Food & Drug Administration (FDA) for its clinical programme to test elacytarabine as a treatment for patients with acute myeloid leukaemia. Elacytarabine is being assessed in a Phase III trial designed to compare elacy

Clavis Pharma ASA has been granted fast-track designation by the US Food & Drug Administration (FDA) for its clinical programme to test elacytarabine as a treatment for patients with acute myeloid leukaemia.

Elacytarabine is being assessed in a Phase III trial designed to compare elacytarabine with the investigator's choice of treatment in patients with late-stage acute myeloid leukaemia.

The primary objective of the study is to compare the overall survival in patients treated with elacytarabine versus those treated with the investigator's choice.

Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine (Ara-C) for the treatment patients with acute myeloid leukaemia and other haematological malignancies (leukaemias), which has the ability to enter cancer cells independently of a specific cellular uptake mechanism.

The Phase III trial will enrol 350 patients at 65 sites in the US, Canada, Australia and Europe, and the company expects to announce the top-line results in the second half of 2012.

The study results, if positive, will be used by the company to support regulatory filings in the US and Europe.

A Phase II trial revealed that elacytarabine showed a statistically significant median survival benefit of 5.3 months, compared to 1.5 months in patients with late-stage acute myeloid leukaemia.

Fast-track designation is granted to facilitate the development and expedite the review of the drugs which treat serious diseases and address an unmet clinical need.