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news.Sunesis Pharmaceuticals has announced the dosing and randomization of first patient in its Vosaroxin multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 VALOR trial in conjuction with cytarabine in patients suffering from first relapsed or refractory acute myeloid leukemia (AML).
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The VALOR trial is expected to recruit 450 evaluable patients at sites in the US, Canada, Europe, Australia and New Zealand.
In the VALOR trial, the patients will be randomized one-to-one to receive in a blinded manner either Vosaroxin or placebo on days one and four of each treatment cycle in combination with cytarabine daily for five days of each treatment cycle.
Sunesis Pharma said that the primary endpoint of the trial is overall survival.
Sunesis Pharma CEO Daniel Swisher said that the initiation of VALOR marks the culmination of many years of work and is a gratifying moment for Sunesis in its ongoing efforts to develop a new therapeutic option for AML patients.
VALOR principal investigator Farhad Ravandi said that Vosaroxin’s differentiated treatment profile from the Phase 2 program is characterized by strong remission rates, low all-cause early mortality and long leukemia free survival, which have led to survival outcomes that compare favorably with published results for current treatment standards.