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.