Sunesis Announces Positive Phase 2 Data for Vosaroxin in AML
For the fully enrolled relapsed/refractory AML study, a total of 69 patients with first relapse or primary refractory AML have been treated at doses of 80 to 90 mg/m(2) of vosaroxin, in combination with bolus or continuous infusion cytarabine. Consistent with results presented at the
These updated clinical findings continue to support Sunesis' plan to initiate the VALOR trial, a multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of vosaroxin in combination with cytarabine in a relapsed/refractory AML patient population expected to begin in the fourth quarter of this year.
"The successful treatment of relapsed or refractory AML requires a durable complete remission and low all-cause early mortality with the ultimate goal of getting the patient to transplant, a combination of outcomes observed in this study," said Dr. Stuart, a clinical study investigator for the trial and member of the VALOR trial steering committee. "Particularly noteworthy is the long leukemia free survival seen among patients who had a complete remission. These mature data provide encouraging evidence of clinically meaningful benefit for this novel combination in patients with limited treatment options. I hope this benefit will be confirmed in the upcoming VALOR trial which is rigorously designed to demonstrate a clinically meaningful survival advantage over a current standard of care."
Sunesis anticipates initiating VALOR, a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML, in the fourth quarter of 2010. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the U.S. and
About Vosaroxin (formerly voreloxin)
Vosaroxin, formerly known as voreloxin, is a first-in-class anticancer 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. Sunesis plans to initiate the VALOR trial, a multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of vosaroxin in combination with cytarabine in a relapsed/refractory AML patient population, in the fourth quarter of 2010.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
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 vosaroxin's efficacy, safety profile and effects as a single agent and in combination with other AML treatments, the planned commencement and timing of the VALOR trial, and results that may warrant further clinical evaluation of vosaroxin. Words such as "achieved," "support," "will," "designed" 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, the risk that unfavorable economic and market conditions may make it more difficult and costly to raise additional capital, the risk that the VALOR trial may not be initiated on the anticipated timeline and 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
Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717
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