Sunesis Completes Enrollment In Phase 2 Voreloxin Trial

Sunesis Pharmaceuticals (Sunesis) has completed enrollment in the REVEAL-1 (Response Evaluation of VorEloxin in AmL) trial. Its a phase 2 dose regimen optimisation trial of single agent voreloxin in newly diagnosed elderly acute myeloid leukemia (AML) patients, who are unlikely to benefit from standard induction chemotherapy.

Reportedly, a total of 113 patients were enrolled and dosed according to one of three dosing schedules. 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).

Additionally, the company said that the trial will also measure the duration of remission and survival. Patients enrolled in the trial were treated with voreloxin according to one of three dosing schedules, 72mg/m2 of voreloxin dosed weekly for three weeks, 72mg/m2 of voreloxin dosed weekly for two weeks, or 72 or 90 mg/m2 of voreloxin dosed on days one and four.

Daniel Swisher, CEO of Sunesis, said: “The REVEAL-1 trial’s rapid accrual from initiation in May 2008 underscores a strong interest from investigators in voreloxin as a potential new treatment for AML. Previously reported interim data from this and other studies have demonstrated that voreloxin can induce durable complete remissions in a variety of AML patient populations, including highly underserved elderly patients. Results from REVEAL-1 and our ongoing Phase 1b/2 trial of voreloxin in combination with cytarabine in relapsed/refractory AML will contribute greatly to our clinical development strategy as we look to move next year into a pivotal trial of voreloxin.”