Sunesis initiates Phase II trial of leukemia drug

The Reveal-1 trial is being conducted in previously untreated elderly patients with acute myeloid leukemia (AML) who are unlikely to benefit from standard induction therapy. Patients enrolled in the trial will receive three weekly doses of 72mg/m2 of voreloxin in a treatment cycle. Approximately 55 patients will be enrolled in the open-label, multi-center Reveal-1 trial.

The primary objective of the Reveal-1 trial is to evaluate voreloxin’s anti-leukemic activity as a single agent, measured as either complete remission (CR) or complete remission without full platelet recovery (CRp). The study will also measure the duration of these responses.

Sunesis has also announced that voreloxin has been accepted as the nonproprietary name for SNS-595 by the United States Adopted Names (USAN) council, in consultation with the WHO International Nonproprietary Names Expert Committee.

Daniel Adelman, senior vice president, development and chief medical officer of Sunesis, said: “Based on the clinical activity and tolerability profiles observed in our Phase I trial of voreloxin in relapsed or refractory AML patients, we see a clear opportunity for this drug in the first-line treatment of older patients who may not benefit from standard induction therapy.”