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news.Talon Therapeutics has enrolled and dosed first patient in the Phase 3 confirmatory study of Marqibo in adult patients with newly diagnosed Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).
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The multicenter, randomized study is designed to evaluate the substitution of Marqibo (Vincristine Sulfate Liposome Injection, VSLI) for standard Vincristine Sulfate Injection (VSI) in the induction, intensification, and maintenance phases of combination chemotherapy.
The primary objective of HALLMARQ study is to compare overall survival (OS) among subjects 60 years of age and older with newly diagnosed ALL.
Talon board member, president and chief executive officer Steven Deitcher said, "We believe Marqibo as part of a multi-drug treatment regimen has the potential to improve the outcomes for patients with newly diagnosed Ph- ALL and we are pleased the HALLMARQ Study which is being conducted under an SPA has commenced enrolment."
Marqibo is a novel, targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine.