* 30% CR/CRi Rate in First 33 rALLy Subjects * rALLy Study Expected to Reach Target Enrollment by Mid-Year * Encouraging Survival in Metastatic Uveal Melanoma Trial
SOUTH SAN FRANCISCO, Calif., June 2, 2009 (GLOBE NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care, presented updated data for Marqibo(r) (vincristine sulfate liposomes injection) for the treatment of adult acute lymphoblastic leukemia (ALL) in second relapse and data from metastatic uveal melanoma at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place May 29-June 2, 2009 in Orlando, Florida.
Hana presented efficacy and safety data from the company's ongoing pivotal rALLy clinical trial for the treatment of adult ALL in second relapse. The updated analysis revealed that ten subjects, or 30 percent, of the first 33 evaluable subjects achieved a complete response (CR) or CR without full blood count recovery (CRi). Hana had previously reported that nine of the first 29 evaluable subjects achieved a CR or CRi. The poster also confirmed that Marqibo has a predictable safety profile with no unexpected toxicities.
Hana is currently targeting an enrollment of at least 56 evaluable subjects and recruitment is on target to complete by mid-2009. The primary objective of the rALLy study 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. The rALLy trial is currently being conducted at thirty-one clinical sites in the U.S., Canada, Germany, Israel and the United Kingdom. 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.
"We continue to be strongly encouraged by the updated results of our ongoing rALLy pivotal trial," said Anne Hagey, M.D., chief medical officer of Hana Biosciences. "These updated efficacy results further support our plans to submit a New Drug Application following completion of rALLy."
Hana also presented efficacy and safety data from the company's recently completed Phase 2 clinical trial for the treatment of metastatic uveal melanoma. The analysis revealed that after a median of four cycles of bi-weekly Marqibo, nine subjects, or 30 percent, of the 30 evaluable subjects achieved durable stable disease of at least 12 weeks. Nineteen subjects continue to be followed for survival, with three subjects being followed for greater than one year, and median overall survival has not yet been met.
About Marqibo(r) (vincristine sulfate liposomes injection)
Marqibo is a novel, targeted, Optisomal(tm) formulation of vincristine, 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. Vincristine is approved by the U.S. Food and Drug Administration as a single agent and in combination regimens for the treatment of hematologic malignancies such as lymphomas and leukemias. Vincristine, a microtubule inhibitor, kills cancer cells when they enter a very specific point in the cell cycle, and its efficacy is concentration- and exposure duration-dependent. Marqibo is designed to enhance the penetration and retention of vincristine at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike regular vincristine, Marqibo is dosed based on patient body surface area without the need to limit the dose to avoid early dose-limiting neurotoxicities.
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.