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Hana Biosciences Announces Successful Planned Independent Safety Analysis Supports Ability to Complete Pivotal rALLy Clinical Trial of Marqibo, Its Lead Novel Anti-Cancer Compound
Date:3/2/2009

ycle of weekly Marqibo treatment. Safety was assessed in the context of efficacy defined as the achievement of a complete response with or without full blood count recovery.

Susan O'Brien, M.D., professor in the leukemia department at the University of Texas MD Anderson Cancer Center in Houston, and rALLy study lead investigator, said, "Clinical results from rALLy, as well as in previous ALL trials, suggest that Marqibo could offer a unique salvage therapy for relapsed ALL and therapeutic advantage over standard vincristine-containing chemotherapy in patients with lymphoid malignancies."

The primary objective of the rALLy study is to assess the efficacy and safety of single-agent, weekly Marqibo 2.25 mg/m2 with dosing based on actual body surface area without the dose capping applied to standard vincristine. Secondary objectives include evaluation of safety, response duration, and overall survival. The patient population is defined as Philadelphia chromosome- negative adult patients in second relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone stem cell transplantation. The rALLy trial is currently being conducted at thirty-one clinical sites in the U.S., Canada, Germany, Israel and the United Kingdom.

Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation from the European Medicines Evaluation Agency in adult ALL.

About Marqibo(R) (vincristine sulfate liposomes injection)

Marqibo is a novel, targeted, Optisomal(TM) formulation of vincristine, 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. Vincri
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SOURCE Hana Biosciences, Inc.
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