SOUTH SAN FRANCISCO, Calif., Dec 2, 2009 (GlobeNewswire via COMTEX News Network) -- Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it has completed enrollment of 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, enrolling a total of 65 patients. The Company chose to exceed its enrollment target of 56 subjects, which was reached in August 2009, to collect a more robust pharmacokinetic data set in the adult ALL patient population. Patients have been enrolled and dosed at 22 sites in the United States, Canada, Germany, and Israel.
"We would like to thank all the clinical investigators, patients and Hana employees whose efforts have allowed us to not only complete enrollment in our pivotal Phase 2 rALLy trial, but exceed our enrollment target. Enrolling more than the targeted number of patients provides us with important pharmacokinetic data," said Anne Hagey, M.D., Chief Medical Officer of Hana Biosciences. "Our sights are now set on reporting top-line results of the rALLy trial at the 2009 American Society of Hematology Meeting."
In June, during the 44th Annual American Society of Clinical Oncology (ASCO) Meeting, Hana announced preliminary data from the Phase 2 rALLy clinical trial, which showed encouraging anti-leukemic activity in a relapsed/refractory adult ALL patient population, enabling several patients to receive a potentially curative stem cell transplant. Data presented at ASCO also showed encouraging preliminary response duration and overall survival data, as well as a predictable safety profile with no unexpected toxicity.
The primary objective of the pivotal Phase 2 rALLy clinical trial 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 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.
About Marqibo(R) (vincristine sulfate liposomes injection)
Marqibo is a novel, targeted, Optisome 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. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the use of proceeds from Hana's recently-completed financing, expected data and results from the rALLy study, as well as the timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential NDA filings and commercialization efforts of Hana's product candidates; and statements regarding the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that the results of the rALLy study will be sufficient to support an NDA filing for Marqibo, or that even if filed, such NDA will be approved by the FDA. In addition, there is no assurance that any of Hana's development efforts relating to its other product candidates will be successful, that Hana will be able to obtain regulatory approval of any of its product candidates, and that the results of clinical trials will support Hana's claims or beliefs concerning the effectiveness of its product candidates. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2008 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
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SOURCE: Hana Biosciences, Inc.
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