Hana Biosciences Announces New Positive Interim Efficacy Results in Pivotal rALLy Clinical Trial of Marqibo in Acute Lymphoblasti... (

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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

- 31% COMPLETE RESPONSE RATE

- MEDIAN SURVIVAL OF 10.5 MONTHS IN COMPLETE RESPONDERS

- FINAL DATA TARGETED FOR 2009 ASH ANNUAL MEETING

SOUTH SAN FRANCISCO, Calif., March 3 /PRNewswire-FirstCall/ -- Hana Biosciences (Nasdaq: HNAB) today announced new positive preliminary efficacy results from a planned interim analysis of the ongoing pivotal rALLy clinical trial evaluating Marqibo(R) (vincristine sulfate liposomes injection) for the treatment of adult acute lymphoblastic leukemia (ALL) in second relapse. The analysis revealed that nine patients, or 31 percent, of the first 29 evaluable subjects achieved a complete response (CR) or CR without full blood count recovery (CRi). The estimated median overall survival (OS) in responders was 10.5 months compared to 5.1 months in non-responders at the time of the data cutoff. Because six of the nine CRs were still alive at that time, the median OS in this group may prove to be longer.

Since the outset of the rALLy trial, the target response rate for the study has been 16% complete responses (i.e., CR or CRi), which equates to nine or more out of the target evaluable population of 56 subjects. Completion of rALLy will satisfy the Company's need for greater than 100 Marqibo-treated adult ALL patients and catalyze the completion and submission of a New Drug Application for accelerated approval.

"We are strongly encouraged by these excellent preliminary results that show we have already met our overall study goal with regards to the number of complete responses in the first 29 patients, and importantly corroborate previously reported Marqibo activity in past clinical trials," said Steven R. Deitcher, M.D., president and chief executive officer. "These data fully support our plans to submit a New Drug Application for accelerated approval of
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SOURCE Hana Biosciences
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