Sunesis Announces Presentation of Adaptive Study Design for Vosaroxin Phase 3 VALOR Trial in AML at ASCO 2011 Annual Meeting

Sunesis Pharmaceuticals, Inc. SNSS today announced the presentation of the adaptive study design for its Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia at the Trials in Progress Poster Session of the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. The poster (Poster #48G), entitled "Adaptive design of VALOR, a phase 3 trial of vosaroxin or placebo in combination with cytarabine for patients with first relapsed or refractory acute myeloid leukemia," is available on the Sunesis website at www.sunesis.com. VALOR, a Phase 3, multinational, randomized, double-blind, placebo-controlled, pivotal trial, is expected to enroll 450 evaluable patients at leading sites in the U.S., Canada, Europe, Australia and New Zealand. Its adaptive design provides for a single interim analysis by an independent Data and Safety Monitoring Board, which will meet to examine pre-specified efficacy and safety data sets and decide whether to implement a one-time sample size adjustment of 225 additional evaluable patients to maintain adequate power across a broad range of clinically meaningful and statistically significant survival outcomes. The interim analysis by the DSMB is expected to take place in mid-2012. Unblinding of the trial is currently expected in 2013. VALOR clinical trial sites have now been opened in all regions (North America, Europe and Australia/New Zealand) with more than 80 sites expected to be open within the next several months.