SOUTH SAN FRANCISCO, Calif., April 22, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that complete data from its pivotal study of Marqibo® in patients with relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL), have been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois.
The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.
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 to deliver 2.25mg/m2 of vincristine 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
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®, 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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Forward-Looking Statement
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 regulatory processes, including potential NDA filings and other regulatory submissions relating to Marqibo, and clinical development of Marqibo; and statements regarding the potential of Marqibo to replace existing therapies and 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 any of Hana's clinical and regulatory development efforts relating to Marqibo will be successful; that the data of the rALLy trial will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; and that the results of the rALLy trial and other clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, 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 Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on November 16, 2009. Hana assumes no obligation to update these statements, except as required by law.