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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

SOUTH SAN FRANCISCO, Calif., March 2 /PRNewswire-FirstCall/ -- Hana Biosciences (Nasdaq: HNAB) today announced that an Independent Data Monitoring Committee (IDMC) has completed a planned, pre-specified safety review of interim data from the ongoing pivotal rALLy clinical trial of Marqibo(R) (vincristine sulfate liposomes injection) for the treatment of adult acute lymphoblastic leukemia (ALL) in second relapse. The results of the IDMC review continue to support the acceptable safety profile observed with Marqibo in earlier studies and no new safety concerns were identified. The IDMC has recommended that the trial continue to completion per protocol.

The Company has accrued 42 patients, or 75 percent, of the total target enrollment of 56 evaluable patients. Recruitment is on target to complete in mid-2009. Results of the Company's planned interim efficacy analysis are forthcoming.

"The IDMC's recommendation to continue the rALLy trial represents an important milestone in the development of Marqibo and towards our goal of developing a therapeutic for this very sick patient population," stated Anne Hagey, M.D., vice president and chief medical officer of Hana Biosciences. "Thanks to our enthusiastic and committed investigators, patient enrollment remains on track. We target The 2009 American Society of Hematology Annual Meeting for a complete data presentation and look forward to submitting a New Drug Application for accelerated approval of Marqibo in 2010."

The interim analysis was designed to assess the safety data of the trial collected to date and also focus on logistical issues such as accrual, retention, and quality of clinical and laboratory data. This interim assessment was based upon a planned evaluation of safety data from the first 29 patients in the study who received at least one c
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SOURCE Hana Biosciences, Inc.
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