56th Subject Enrolled and Dosed
Data Presentation Targeted for 2009 ASH Annual Meeting
NDA Submission Targeted for First Half of 2010
SOUTH SAN FRANCISCO, Calif., Aug. 12, 2009 (GLOBE NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), today announced it has achieved its enrollment goal of 56 evaluable subjects in the 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. Hana announced in June 2009, during the 44th Annual ASCO Meeting, that ten subjects, or 30 percent, of the first 33 evaluable subjects achieved a CR or CRi. 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. Hana expects the final patient data to be available by year-end and, assuming positive results, plans to file its NDA seeking accelerated approval in the first half of 2010.
"We are grateful to our study subjects, their families, and the treating physicians for helping Hana achieve this important milestone," said Anne Hagey, M.D., chief medical officer of Hana Biosciences. "This accomplishment sets the stage for further data analysis, data dissemination, and regulatory submissions intended to make Marqibo available to more patients with leukemia."
About Marqibo(r) (vincristine sulfate liposomes injection)
Marqibo is a novel, targeted, Optisomal(tm) 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 conventional 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. (Nasdaq:HNAB) is a biopharmaceutical company dedicated to developing new, differentiated cancer therapies designed to improve and enable current standards of care. The company has two lead product candidates that target large markets and are in pivotal and/or proof-of-concept clinical trials. Marqibo(r) is being developed to treat lymphoid cancers such as ALL and lymphomas. Menadione topical lotion is a first-in-class compound being developed as a prevention and/or treatment of skin toxicity associated with epidermal growth factor receptor inhibitors like Erbitux(r) and Tarceva(r). The Company has additional pipeline opportunities that, like Marqibo, improve delivery and enhance the therapeutic index of well characterized, proven chemotherapies. Further 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 timing progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings and commercialization efforts of Hana's product candidates; statements regarding the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies; statements regarding the availability of additional capital, including capital subject to Hana's existing loan facility; and statements regarding Hana's efforts to enter into strategic collaborations regarding the development or commercialization of its product candidates. 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 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.