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news.Clavis Pharma has been granted fast track designation by the US Food & Drug Administration (FDA) for its clinical programme with elacytarabine for the treatment of patients with acute myeloid leukaemia (AML).
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Elacytarabine is a novel, patented lipid-conjugated (LVT) form of the anti-cancer drug cytarabine (Ara-C) for the treatment patients with AML and other haematological malignancies (leukaemias), which has the ability to enter cancer cells independently of a specific cellular uptake mechanism.
Elacytarabine is currently being assessed in a Phase III trial, which is designed to compare elacytarabine with the investigator’s choice of treatment in patients with late-stage AML.
The primary objective of the study is to compare the overall survival in patients treated with elacytarabine versus those treated with investigator’s choice.
The Phase III trial will enroll 350 patients at 65 sites in 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 AML.
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.