We are currently evaluating vosaroxin in 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. We are 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.
Vosaroxin has demonstrated objective tumor responses in a variety of tumor types and has been generally well tolerated. Clinical responses with single agent vosaroxin have been seen in these indications, as well as in non-small cell and small cell lung cancers. In addition, complete remissions have been observed in AML patients treated with vosaroxin in combination with cytarabine.
Vosaroxin is a replication-dependent DNA-damaging agent that induces G2 arrest and apoptosis (cell death). As a result, cancer cells, which are typically proliferative and resistant to pathways that eliminate damaged or aberrant cells, are no longer able to divide and the cells die. Based on our translational research and our understanding of Vosaroxin's mechanism of action, vosaroxin has the potential to combine with other anticancer agents for the treatment of both advanced and earlier stage disease. Click here for more information on vosaroxin's mechanism of action.