"The completion of VALOR's interim analysis is an important milestone for Sunesis," said Daniel Swisher, Chief Executive Officer of Sunesis. "In light of the design of VALOR, the DSMB's recommendation that we implement a one-time, 225-patient sample size increase is a promising development. We thank the DSMB for their comprehensive analysis, and trial investigators for their continued support of VALOR, which has now enrolled 412 patients. Importantly, we are pleased that we have committed funding that will allow us to implement this enrollment expansion and complete the pivotal trial in AML."
Sunesis' management and staff, VALOR clinical investigators, including members of the Study Steering Committee, and Royalty Pharma remain blinded to the interim trial data and analysis.
Royalty Pharma's $25.0 million investment is made pursuant to the terms of an agreement with Sunesis announced March 29, 2012. In exchange for their investment, Royalty Pharma will receive a 6.75% royalty on future net sales of vosaroxin and warrants to purchase Sunesis common stock.
Conference Call Information
Sunesis will host an update conference call today, September 11th at 9:00 a.m. Eastern Time. The call can be accessed by dialing (866) 700-6293 (U.S. and Canada) or (617) 213-8835 (international), and entering passcode 65702894. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at
. The webcast will be recorded and available for replay on the company's website for two weeks.
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 110 leading sites in the U.S., Canada, Europe, 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
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.