SOUTH SAN FRANCISCO, CA, USA I June 13, 2013 I Sunesis Pharmaceuticals, Inc. (SNSS) today announced that the independent Data and Safety Monitoring Board (DSMB) for the VALOR trial has completed its latest periodic safety review and recommended that the trial continue as planned without changes to study conduct. The VALOR trial is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin, Sunesis‘ lead product candidate, in patients with first relapsed or refractory acute myeloid leukemia (AML).
“The DSMB recommendation to continue VALOR is an important milestone, and affirms our confidence in VALOR, the largest industry-sponsored trial undertaken in this disease setting, and in vosaroxin, a drug with significant potential in the treatment of AML,” said Adam R. Craig, MD, PhD, Executive Vice President, Development and Chief Medical Officer of Sunesis. “With this safety review behind us, we now look ahead to completion of enrollment, expected in 2013, then the unblinding of VALOR, which is expected to occur in the first half of 2014.”
About VALOR
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 approximately 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 in a ratio of 1:1 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 www.valortrial.com.
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 AML. 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.
About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 14,590 new cases of AML and approximately 10,370 deaths from AML in the U.S. in 2013. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 50,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Sunesis Pharmaceuticals
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.
SOURCE: Sunesis Pharmaceuticals
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SOUTH SAN FRANCISCO, CA, USA I June 13, 2013 I Sunesis Pharmaceuticals, Inc. (SNSS) today announced that the independent Data and Safety Monitoring Board (DSMB) for the VALOR trial has completed its latest periodic safety review and recommended that the trial continue as planned without changes to study conduct. The VALOR trial is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin, Sunesis‘ lead product candidate, in patients with first relapsed or refractory acute myeloid leukemia (AML).
“The DSMB recommendation to continue VALOR is an important milestone, and affirms our confidence in VALOR, the largest industry-sponsored trial undertaken in this disease setting, and in vosaroxin, a drug with significant potential in the treatment of AML,” said Adam R. Craig, MD, PhD, Executive Vice President, Development and Chief Medical Officer of Sunesis. “With this safety review behind us, we now look ahead to completion of enrollment, expected in 2013, then the unblinding of VALOR, which is expected to occur in the first half of 2014.”
About VALOR
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 approximately 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 in a ratio of 1:1 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 www.valortrial.com.
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 AML. 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.
About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 14,590 new cases of AML and approximately 10,370 deaths from AML in the U.S. in 2013. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 50,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Sunesis Pharmaceuticals
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.
SOURCE: Sunesis Pharmaceuticals
Post Views: 153
