SOUTH SAN FRANCISCO, Calif., Sep 30, 2009 (GlobeNewswire via COMTEX News Network) -- Hana Biosciences (OTCBB:HNAB) today announced that the Company has entered into a Clinical Trial Agreement (CTA) with the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) for the co-development of Marqibo(R) (vincristine sulfate liposomes injection) in refractory pediatric cancer.
The five-year CTA with the CCR will initially focus on a Phase 1 trial to evaluate the safety, preliminary efficacy, pharmacokinetic profile, and optimal dose of weekly Marqibo in children and adolescents with refractory cancer. Following this Phase I trial, the Company and CCR plan a Phase 2 trial in pediatric acute lymphoblastic leukemia (ALL), the most common cancer of childhood. The Company anticipates that this Phase 2 trial will facilitate subsequent studies of Marqibo in combination with standard chemotherapy regimens, and hopes that these in turn will lead to further improvements in the outcome for childhood cancer in the future. Dr. Alan Wayne, Clinical Director, Pediatric Oncology Branch, National Cancer Institute, National Institutes of Health will serve as the principal investigator.
To date, Marqibo has been studied at a single dose level in 29 pediatric and adolescent subjects. Subjects had relapsed cancers including soft tissue sarcoma, osteosarcoma, Wilms' tumor, or ALL. Marqibo was determined to be generally tolerable and safe at the studied dose and resulted in a disease control rate of 34 percent in this very sick patient population.
"This agreement expands the clinical development programs for Marqibo and will complement our pivotal Phase 2 rALLy clinical trial evaluating Marqibo for the treatment of adults with ALL in second relapse," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "Our combined effort with the NCI will further increase our understanding of Marqibo's unique activity and ability to supplant standard vincristine in children as well as adults."
"Our agreement with the NCI signifies the importance of vinca alkaloids like vincristine in the treatment of pediatric ALL and solid tumors like Wilm's tumor, rhabdomyosarcoma, and neuroblastoma" said Anne Hagey, M.D., Chief Medical Officer of Hana Biosciences. "The ability to enhance the dosing, tumor penetration, and pharmacokinetic profile of vincristine by the Marqibo formulation has the potential to improve outcomes in children with cancer, a typically underserved area of drug development."
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. Marqibo is currently being studied in a pivotal registration trial for patients in second relapse with ALL.
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 has two lead product candidates that target large markets and are in pivotal and/or proof-of-concept clinical trials. Marqibo(R) potentially treats acute lymphoblastic leukemia and lymphomas. Menadione Topical Lotion is a first-in-class compound for the potential prevention and/or treatment of skin toxicity associated with epidermal growth factor receptor inhibitors. The Company has additional pipeline opportunities that, 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 timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings and commercialization efforts of Marqibo; and statements regarding the expected benefits Marqibo may have for patients with 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 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 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, both as filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
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