Our highly experienced cancer drug development organization is committed to advancing our lead drug candidate, vosaroxin, through clinical trials. Vosaroxin is currently being evaluated in our Phase 3 VALOR trial, a multi-national, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine in patients with relapsed or refractory AML. The VALOR trial is designed to evaluate the effect of vosaroxin in combination with cytarabine, a widely used chemotherapy in AML, on overall survival as compared to placebo in combination with cytarabine. The trial design was based on compelling results from Phase 2, where strong remission rates, low all cause mortality and long leukemia free survival were observed, leading to promising survival outcomes.
We are also in the survival follow-up stage of two fully-enrolled clinical trials of vosaroxin: the Phase 2 portion of a Phase 1b/2 trial of vosaroxin in combination with cytarabine for the treatment of patients with first relapsed or primary refractory AML, and a Phase 2 trial (known as REVEAL-1) in previously untreated elderly patients with AML, which explored three different dose schedules. In addition, we completed a Phase 2 single agent trial of vosaroxin in platinum-resistant ovarian cancer patients in 2010, which explored three different dose cohorts.
In clinical trials conducted to date, vosaroxin has been generally well tolerated and has shown objective responses in both solid and hematologic tumor types.
Our vosaroxin development program has benefited from nonclinical, translational research providing us with an in-depth understanding of a compound's mechanism and potential activity. These insights ensure that vosaroxin demonstrates a strong, differentiated pharmaceutical profile and informs clinical trial design, with a view to increase efficiencies and reduce risks.