SOUTH SAN FRANCISCO, Calif., Oct. 25, 2007 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, presented results from preclinical studies of three of the company's product candidates, Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)), Alocrest(tm) (vinorelbine tartrate injection, OPTISOME(tm)), and Brakiva(tm) (topotecan hydrochloride injection, OPTISOME(tm)) at the "Molecular Targets and Cancer Therapeutics" International Conference sponsored by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI), and the European Organization for Research and Treatment of Cancer (EORTC).
"We believe our Optisome platform may offer distinct advantages to cell-cycle specific chemotherapeutics by essentially transforming these traditional cytotoxics into targeted medicines, enhancing their activity and maximizing their potential benefit," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "Data presented today support our clinical plans and regulatory strategies for these exciting compounds by reinforcing our understanding of how each Optisome candidate may provide unique advantages in the treatment of cancer."
Hana reported results from three preclinical studies, conducted on Marqibo, Alocrest, and Brakiva, that evaluated and compared the tissue distribution and/or pharmacokinetic (PK) profiles of Optisome formulations of vincristine, vinorelbine and topotecan versus the respective non-encapsulated drugs. Normal or tumor-bearing animals were administered either the conventional chemotherapeutic agent, or with an equivalent amount of the same drug encapsulated in Optisomes, Hana's nanoparticulate carrier. Where studied, Optisome encapsulated drugs preferentially accumulated in implanted tumors and other target tissues.
Data was presented today during Poster Session C - Novel Drug Delivery Systems. Taken together, these data indicate that each of Hana's Optisome-enhanced compounds may have the potential for enhanced anti-tumor activity without increased toxicity.
* Abstract #C111 - "Vincristine sulfate liposomes injection
concentrates vincristine in tumor tissue and bone marrow of
tumor-bearing mice." The ability of Marqibo to target drug
to the bone marrow, lymph nodes, and spleen makes it
particularly attractive as a treatment for hematologic
malignancies such as myelomas, lymphomas and leukemias where
vincristine has been approved by the U.S. Food and Drug
Administration as a single anti-cancer agent and in
combination therapeutic regimens. Marqibo is currently in
a registration enabling study in adult relapsed acute
lymphoblastic leukemia (ALL), the rALLy study.
* Abstract #C109 - "Vinorelbine liposomes injection results in
greater tumor drug exposure compared to conventional
vinorelbine in tumor-bearing nude mice." Alocrest is
currently in a Phase 1 dose-escalating clinical trial.
Vinorelbine (Navelbine(r)) has been approved for use as
a single agent or in combination with cisplatin for the
first-line treatment of advanced non-small cell lung cancer,
and in several countries it is also approved for the
treatment of advanced-stage breast cancer.
* Abstract #C113 - "A pharmacokinetic study of a novel
sphingomyelin/cholesterol liposomal topotecan and nonliposomal
topotecan in rats." Hana is currently planning clinical
trials to evaluate the safety and efficacy of Brakiva.
Topotecan hydrochloride (Hycamtin(r)) is approved for
treatment of metastatic carcinoma of the ovary, and relapsed
non-small cell lung carcinoma (NSCLC), and recently received
approval for use in small cell lung carcinoma.
About OPTISOME(tm) Nanoparticle Technology
Optisomes are a new generation of unique sphingomyelin/cholesterol-based nanoparticles designed to encapsulate cell cycle-specific chemotherapeutics designed for improved efficacy with reduced toxicity. Optisomes are approximately 100 nanometers in diameter and able to encapsulate and transport cancer drugs preferentially to tumor sites. While too large to easily migrate out of normal blood vessels, Optisomes are able to migrate across the more "leaky" vasculature of a tumor, resulting in higher concentrations of drugs at tumor sites than in normal tissue. Optisomes' unique sphingomyelin-cholesterol composition is particularly well suited to cell cycle-specific agents such as vincristine, vinorelbine and topotecan. The relative rigidity of the Optisomes' outer shell results in a long circulating half-life and sustained drug release at the tumor site, which may increase tumor cell exposure during the most vulnerable phases of cell division. Combined, these factors are key to the Optisome advantage as sustained drug exposure increases tumor cell death. Hana's Optisome pipeline includes Marqibo(r) (vincristine), Alocrest(tm) (vinorelbine) and Brakiva(tm) (topotecan).
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (Nasdaq:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care cancer care. The company is committed to creating value by building a best in-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. 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 potential advantages of Marqibo, Alocrest and Brakiva over current therapies, 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, including Marqibo, Alocrest and Brakiva. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.