Sunesis Pharmaceuticals Inc. (SNSS) announced that the independent Data and Safety Monitoring Board or DSMB for the VALOR trial has completed its latest periodic safety review and recommended that the trial continue as planned without changes to study conduct.
The VALOR trial is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin, Sunesis' lead product candidate, in patients with first relapsed or refractory acute myeloid leukemia or AML.
"With this safety review behind us, we now look ahead to completion of enrollment, expected in 2013, then the unblinding of VALOR, which is expected to occur in the first half of 2014," said Adam Craig, Executive Vice President, Development and Chief Medical Officer of Sunesis.
Vosaroxin is a first-in-class anti-cancer quinolone derivative or AQD, a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.
The company stated that both the U.S. Food and Drug Administration or FDA and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory acute myeloid leukemia in combination with cytarabine.
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