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Hana Biosciences Announces New Positive Interim Efficacy Results in Pivotal rALLy Clinical Trial of Marqibo in Acute Lymphoblastic Leukemia
Date:3/3/2009

Marqibo upon successful completion of rALLy and mark another in a series of milestone achievements in recent months that underscore our ability to execute in terms of product development."

"These exciting data bring us another step closer to making this promising treatment available to this very sick ALL patient population for whom there are currently no approved or standard therapies," stated Anne Hagey, M.D., vice president and chief medical officer. "Marqibo may enable high-potency dosing of vincristine chemotherapy and improve efficacy versus standard vincristine without increased toxicity."

Yesterday, Hana Biosciences announced the findings from a planned, pre-specified safety review of data from the rALLy trial conducted by an Independent Data Monitoring Committee (IDMC). The IDMC meeting outcome supports an acceptable, manageable safety profile for Marqibo with no new safety concerns. The IDMC has recommended that the trial continue to completion per the protocol. The Company has now accrued greater than 75 percent (43 patients) of the total target enrollment of 56 patients and recruitment is on target to complete by mid-2009.

The primary objective of the rALLy study is to assess the efficacy 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 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 Marq
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SOURCE Hana Biosciences
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