Veolia North America
Environmental Solutions for Energy, Water and Industrial Waste
US firm Sunesis Pharmaceuticals is set to conduct Phase III trials of its drug voreloxin to treat acute myeloid leukaemia (AML), a type of blood cancer characterised by uncontrolled proliferation of immature blast cells in the bone marrow. This follows the completion of formal end-of-Ph
US firm Sunesis Pharmaceuticals is set to conduct Phase III trials of its drug voreloxin to treat acute myeloid leukaemia (AML), a type of blood cancer characterised by uncontrolled proliferation of immature blast cells in the bone marrow.
This follows the completion of formal end-of-Phase II meetings and feedback from the US Food and Drug Administration for the compound.
The randomised double-blind placebo-controlled trial, to begin in the second half of 2o10, will evaluate the overall survival of voreloxin in combination with cytarabine, a widely used chemotherapy treatment for AML, compared to cytarabine with placebo.
Voreloxin is an anticancer quinolone derivative that intercalates DNA and inhibits topoisomerase II, which results in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.
The compound is being evaluated in a fully enrolled single-agent Phase II clinical trial in previously untreated elderly AML patients and in a fully enrolled Phase Ib/II clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML.
The company has also scheduled a pre-submission meeting with the European Medicines Agency for advice on the Phase III trial.
Environmental Solutions for Energy, Water and Industrial Waste
Distribution of Chemical Products, APIs and Pharmaceutical Excipients
Electronic Data Capture Solutions for Clinical Data Management