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Hana Biosciences (OTCBB:HNAB), South San Francisco, a biopharmaceutical company focused on strengthening the foundation of cancer care, has 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 (ALL) 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 (CR) or CR with incomplete hematologic recovery (CRi) 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.

"We are excited by the rALLy trial results for Marqibo in adult ALL that demonstrate an ability to induce meaningful remissions in patients without approved treatment options," said Anne Hagey, M.D., Chief Medical Officer of Hana Biosciences. "Based on the rALLy trial data, other published Marqibo data in adult ALL, and supportive data in lymphomas and solid tumors, we plan to submit a New Drug Application seeking accelerated approval for Marqibo in 2010."

"This important clinical trial adds significantly to our understanding of adult ALL patients in need of effective second salvage therapy," said Susan O'Brien, M.D., Professor of Medicine in the Leukemia Department at the University of Texas, MD Anderson Cancer Center and rALLy study lead investigator. "Based on the rALLy trial data, Marqibo provides clinical benefit and could be a valuable weapon in the fight against leukemia."

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

Phase 2 rALLy Clinical Trial Design and Results

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 (OS), 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 (ORR) 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.

About Marqibo(R) (vincristine sulfate liposomes injection)

Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of vincristine sulfate, 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. Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike standard vincristine, Marqibo is dosed based on actual patient body surface area without the need for dose-capping.

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 in adult ALL from the European Medicines Evaluation Agency.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.

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Publication:Biotech Business
Date:Dec 29, 2009

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