Clavis Pharma ASA has announced data from its Phase II clinical trial with elacytarabine in combination with idarubicin.
The trial enrolled patients with early stage acute myeloid leukaemia (AML), for whom cytarabine-containing first-course chemotherapy has failed and results were presented by Dr David Rizzieri from Duke University Medical Center at the American Society of Haematology annual meeting in Atlanta, GA.
Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine, which is routinely used in the treatment of AML.
The results found that treatment with the elacytarabine/idarubicin combination showed promising clinical activity with a complete remission (CR/CRi) rate of approximately 43% in patients who failed to respond to first-course treatment (20 of 46 evaluable patients).
To date, 13 patients were deemed fit enough following treatment to be referred for stem cell transplantation, which represents a potential cure for these patients.
The safety profile is consistent with this type of cytotoxic therapies.
The main objective of the 51-patient trial is to demonstrate that patients failing cytarabine can be rescued by elacytarabine. The study was conducted at leading haematology clinics in the USA and Europe.
Olav Hellebø, Clavis Pharma CEO, commented: "The results have shown that elacytarabine in combination with idarubicin elicits a therapeutic effect in a substantial proportion of early stage AML patients for whom first-course cytarabine treatment failed. This is very encouraging and highlights the potential of elacytarabine to offer a new treatment option to patients who may not respond to current standard cytarabine-containing therapies. We would like to thank the investigators and their patients for taking part in this study.”