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Hana Biosciences Announces Positive Data From rALLy Marqibo Clinical Trial

December 8, 2009 (FinancialWire) — Hana Biosciences (OTCBB: HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, announced data from its pivotal Phase 2 rALLy clinical trial for Marqibo(R) (vincristine sulfate liposomes injection) for the treatment of adult acute lymphoblastic leukemia in second relapse.

Results from the rALLy trial demonstrated compelling evidence of single-agent, anti-leukemic activity in a relapsed/refractory, heavily pre-treated, adult population of ALL patients, with a universal history of prior exposure to the standard formulation of vincristine sulfate.

The analysis of the first 56 evaluable subjects demonstrated an overall response in 36 percent of the subjects and a complete remission or CR with incomplete hematologic recovery in 21 percent of the subjects. The estimated median overall survival in complete responders was 7.3 months. Fifty percent of the complete responders were able to receive a potentially life-saving stem cell transplant. Fifty percent of the complete responders had remission durations longer than the duration of their prior remission. In addition, Marqibo was generally well-tolerated with a low incidence of early death.

Final data on all 65 subjects enrolled and dosed in the Phase 2 rALLy trial will be presented in 2010.

The pivotal Phase 2 rALLy clinical trial enrolled a total of 65 patients at 22 sites in the United States, Canada, Germany, and Israel. The study achieved its enrollment target of 56 subjects in August 2009, but additional subjects were enrolled to obtain target population pharmacokinetic data. The primary objective of the rALLy clinical trial was to assess the efficacy of single-agent, weekly Marqibo (2.25 mg/m2) as assessed by achievement of CR or CRi.

Secondary objectives included duration of CR/CRi, overall survival, safety and tolerability. Marqibo was dosed weekly based on actual body surface area without the dose capping applied to standard vincristine. The study 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.

An overall response rate as determined by CR, CRi, partial remission, and bone marrow blast count normalization without blood count recovery was reported by investigators in 20 of 56 subjects for an ORR of 36 percent, with 12 of 56 subjects (21 percent) experiencing a CR or CRi. Seven subjects underwent allogeneic stem cell transplant after receiving Marqibo. The median OS in the 56 subjects is estimated to be 4.6 months (range 0.1-15.9) using Kaplan-Meier methodology. The safety profile of Marqibo is predictable, manageable, and similar to vincristine sulfate. Adverse events occurring in greater than 30 percent of subjects include neuropathy, nausea, constipation, pyrexia, decreased appetite, and febrile neutropenia. The early death rate, defined as death occurring within the first 14 days on study, was 5.4 percent (3 of 56 subjects) and occurred due to progressive ALL.

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Free annual reports for companies mentioned in the news are available through the Free Annual Reports Service (http://investrend.ar.wilink.com/?level=279). The most recently issued reports and/or recorded webcasts include Aria International Holdings, Inc. (OTCBB: ARAH), Continental Materials Corp. (AMEX: CUO), Darling International, Inc. (NYSE: DAR), Document Security Systems, Inc. (AMEX: DMC), and Juhl Wind, Inc. (OTCBB: JUHL).

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