New data show that at 12 months newly diagnosed patients taking Tasigna (nilotinib) to treat a life-threatening form of chronic myeloid leukaemia (CML) had rapid responses and a deep reduction in the amount of the abnormal protein that causes this disease.

"Tasigna now demonstrates potential to achieve remarkable responses in newly diagnosed patients," said Gianantonio Rosti, Institute of Haematology Seràgnoli, Bologna University, Bologna, Italy, and lead study investigator. "These positive data suggest that, one day, Tasigna may offer patients another front-line treatment option."

The research compared Tasigna against historical Glivec (imatinib) data in the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML). Findings were presented today at the 14th Congress of the European Haematology Association (EHA) in Berlin, Germany.

Traditionally with Glivec therapy, efficacy in Ph+ CML has been measured with the objective of achieving a complete cytogenetic response (CCyR), or reaching an undetectable level of Philadelphia chromosome cells in a patient's bone marrow. However, through highly sensitive measuring methods, major molecular response (MMR) has emerged as another important measure of efficacy and may be the best predictor of long-term progression-free survival.

Tasigna was specifically designed to inhibit Bcr-Abl -- the abnormal protein responsible for the uncontrolled production of white blood cells that occurs in Ph+ CML patients -- and mutations of Bcr-Abl, more effectively than Glivec. In this phase-II study, the time to achieve MMR was measured as an endpoint. The data indicate that 96 per cent of patients taking Tasigna reached CCyR at 12 months. In this same time period, 85 per cent of patients taking Tasigna achieved MMR. These data indicate a more rapid reduction in disease burden compared to that seen in historical studies with Glivec. In this study, Tasigna was generally well tolerated.

Results from a phase-III registration trial, ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients), evaluating Tasigna as a potential front-line therapy for certain Ph+ CML patients, are expected in early 2010.

Currently, Tasigna is approved in more than 65 countries for the treatment of adult patients with Ph+ CML in the chronic or accelerated phases who are resistant or intolerant to prior treatment, including Glivec.

CML is a disease of the blood and bone marrow in which the body produces cancerous white blood cells.

Glivec is approved in more than 90 countries including the US, EU and Japan, for the treatment of all phases of Ph+ CML.