Sunesis Appoints Joseph I. DePinto as Chief Commercial Officer, Updates VALOR Timeline to Unblinding of Data
"Joe's extensive commercial leadership and expertise in overseeing launch, growth and lifecycle planning of leading oncology products provide immediate leverage to Sunesis as we approach the unblinding of VALOR and prepare to execute successfully on our commercial and regulatory strategies for vosaroxin," said
Sunesis also announced today that, based on a recent evaluation of survival events, the unblinding of the pivotal, Phase 3 VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory acute myeloid leukemia (AML) is now expected in the third quarter of 2014.
Mr. Swisher added: "With survival events occurring at a slower pace than previously forecast, we now expect to unblind VALOR in the third quarter of 2014, rather than the second quarter. We remain well funded to prosecute VALOR beyond the transformative milestone of top-line data readout."
"Vosaroxin is an exciting product candidate, one with significant potential in AML and other related indications, to which Sunesis has retained full global commercial rights," said Mr. DePinto. "I am delighted to join Sunesis at this exciting time to help lead the forward integration of the company with a build out of a preeminent U.S. oncology commercial team to successfully introduce vosaroxin into a population desperately in need of new therapies."
Prior to joining Sunesis, Mr. DePinto was Executive Vice President, Global Commercial Operations at
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial enrolled 712 patients at more than 100 leading sites in the U.S.,
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
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
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This press release contains forward-looking statements, including statements related to the design, conduct, progress, timing and results of the VALOR trial and Sunesis' investigator sponsored trials, and the commercial potential for vosaroxin. Words such as "anticipate," "believe," "expect," "forecast," "leverage," "look forward," "potential," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vosaroxin, the risk that raising funds through lending arrangements may restrict our operations or produce other adverse results, the risk that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the
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