Date: 2012-12-10
Type of information:
phase: 2
Announcement: presentation of phase 2 data at the American Society of Hematology (ASH) annual meeting
Abstract #46: \"A Phase II Study of Elacytarabine/Idarubicin as Second Course Remission-Induction in Patients with Acute Myeloid Leukemia who Failed Cytarabine/Anthracycline.\"December 2012. ASH Oral presentation of CP4055-205 trial by Dr D. Rizzieri
Company: Clavis Pharma (Norway)
Product: elacytarabine
Action mechanism: Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine created by Clavis Pharma using its Lipid Vector Technology (LVT).
Disease: relapsed or refractory acute myeloid leukaemia (AML)
Therapeutic area: Cancer - Oncology
Country: Europe, USA
Trial
details: Fifty one adult patients with AML who have not attained complete remission after the first induction course with a standard-dose cytarabine-anthracycline based regimen were enrolled in the study. Patients received a combination of elacytarabine and idarubicin, as second induction course at a dose of 1000 mg/m2/day continuous infusion of elacytarabine on days 1-5 in combination with idarubicin at 12 mg/m2/day IV days 1-3. Patients treated with further courses received either the combination therapy or elacytarabine monotherapy at 2000 mg/m2/day on days 1-5, at the investigator`s discretion.
Latest
news: Clavis Pharma, a Norwegian cancer drug development company, 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, for whom cytarabine-containing first-course chemotherapy has failed and results were presented by Dr David Rizzieri from Duke University Medical Center yesterday at the American Society of Haematology annual meeting in Atlanta, GA.
The results found that treatment with the elacytarabine/idarubicin combination showed promising clinical activity with a complete remission (CR/CRi - complete remission including complete remission with incomplete blood count recovery) 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."
