Clinical Trial Updates

VALOR enrollment reaches 500 patients. Enrollment in the VALOR Trial, a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin plus cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML), has reached 500 patients. Target enrollment of 675 patients is expected to be complete in 2013, with unblinding of the study data expected in the first half of 2014. VALOR is the largest company-sponsored trial ever conducted in first relapsed or refractory AML.

Enrollment doubles in LI-1 trial. Enrollment in the Less Intensive 1 (LI-1) study, a Phase 3 randomized, controlled trial evaluating novel treatment regimens, including two vosaroxin-containing regimens, in newly diagnosed elderly AML and high-risk myelodysplastic syndrome (MDS) patients, has reached 49 vosaroxin-treated patients. LI-1 is being conducted by the United Kingdom's National Cancer Research Institute under the direction of Professor Alan K. Burnett, Head of Haematology at Cardiff University.

2013 Major Corporate Milestones

  • Completion of enrollment. Sunesis remains on track to complete full enrollment of VALOR in 2013. Enrollment is currently ongoing at more than 100 leading sites in the U.S., Canada, Europe, South Korea, Australia and New Zealand.  
  • Interim safety analysis. Sunesis expects a planned interim safety analysis of VALOR by the trial's independent Data and Safety Monitoring Board (DSMB) to occur in June, 2013.

  • First interim analyses. Sunesis anticipates the first planned interim assessments of the LI-1 trial following enrollment of 50 patients per vosaroxin treatment arm, which are expected to occur in 2013. Currently, various treatment options are being evaluated in a randomized Phase 3 design with key endpoints including complete remission (CR), 12 month survival, and overall survival. Treatment arms that are exhibiting promising results are expected to continue enrolling up to a total of 200 patients enrolled per arm.

  • Initiation of investigator sponsored trials. Sunesis is evaluating additional indications and trials, and expects to support the initiation of additional investigator sponsored trials in MDS and AML at leading centers in 2013.  
  • Expansion of the Intellectual Property Estate. Sunesis expects to secure additional patents in 2013, with the goal of supporting the Company's vosaroxin global patent estate and intellectual property strategy. The Company's multi-layered patent portfolio currently supports market exclusivity for vosaroxin to 2030 in the US, and beyond 2025 in multiple geographies around the world.

Kinase Inhibitor Program
  • Continued progress with partnered kinase inhibitor programs. Sunesis currently has partnered kinase inhibitor programs in oncology with Millennium Pharmaceuticals and immunology with Biogen Idec. 


VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial's target enrollment is 675 patients at more than 100 leading sites in the U.S., Canada, Europe, South Korea, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. The trial's primary endpoint is overall survival. For more information on the VALOR trial, please visit .

The VALOR logo is available at

About Vosaroxin

Vosaroxin is a first-in-class anti-cancer quinolone derivative (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. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of acute myeloid leukemia. 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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