Hana Biosciences, has achieved its enrolment goal of 56 evaluable subjects in the pivotal phase-2 rALLy clinical trial for Marqibo (vincristine sulfate liposomes injection) for the treatment of adult acute lymphoblastic leukaemia (ALL) in second relapse. Hana announced in June 2009, during the 44th Annual ASCO Meeting, that ten subjects, or 30 percent, of the first 33 evaluable subjects achieved a CR or CRi. Data presented at ASCO also showed encouraging preliminary response duration and overall survival data, as well as a predictable safety profile with no unexpected toxicity. Hana expects the final patient data to be available by year-end and, assuming positive results, plans to file its NDA seeking accelerated approval in the first half of 2010.

"We are grateful to our study subjects, their families, and the treating physicians for helping Hana achieve this important milestone," said Anne Hagey, chief medical officer of Hana Biosciences. "This accomplishment sets the stage for further data analysis, data dissemination, and regulatory submissions intended to make Marqibo available to more patients with leukaemia."

Marqibo is a novel, targeted, Optisomal formulation of vincristine sulfate, a widely-used chemotherapy, which has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials.

Hana Biosciences is a biopharmaceutical company dedicated to developing new, differentiated cancer therapies designed to improve and enable current standards of care.