PipelineReview.com - Biotech News & Online Store - Hana Biosciences Presents Positive Preliminary Phase 1 Clinical Data On Alocrest At the AACR-NCI-EORTC International Conference

Hana Biosciences Presents Positive Preliminary Phase 1 Clinical Data On Alocrest At the AACR-NCI-EORTC International Conference

24 Oct 2007

Hana Biosciences today announced the presentation of clinical data for Alocrest(tm) (vinorelbine tartrate 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)

SOUTH SAN FRANCISCO, CA, USA | October 23, 2007 | Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company

focused on strengthening the foundation of cancer care, today announced the presentation of clinical data for Alocrest(tm) (vinorelbine tartrate 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).

Interim data was presented from the first four cohorts of the Phase 1 trial for Alocrest, demonstrating anti-tumor activity with three of eleven patients with refractory solid tumors achieving stable disease. To date, Alocrest has been relatively well tolerated over multiple cycles of therapy.

"The early Phase 1 clinical data suggest that Optisomal encapsulation of vinorelbine may be extending plasma circulation time, targeting drug to sites of tumor, and increasing anti-cancer activity of conventional vinorelbine in patients with advanced, difficult-to-treat cancers. We are hopeful that these effects translate into improved patient outcomes," stated Steven R. Deitcher, M.D., President and Chief Executive Officer. "We are continuing to enroll patients in this Phase 1 trial with a sixth cohort currently underway at a dose that approximates the maximum tolerated dose of conventional vinorelbine."

The ongoing Phase 1 trial is enrolling adult subjects with confirmed solid tumors refractory to standard therapy or for which no standard therapy was known to exist, or with relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease. This data reported on 13 subjects with refractory solid tumors (n=11) and non-Hodgkin's lymphoma (n=2). Patients received Alocrest via a 60-minute IV infusion on days 1 and 8 every 21 days at four dose levels (1.7, 3.3, 6.7, and 13 mg/m2/doses). Stable disease was observed in three refractory solid tumor subjects and no dose limiting toxicities were observed at these dose levels. The maximum-tolerated dose has not yet been reached. A relatively high inter-patient and low intra-patient variability was shown in the pharmacokinetic profile of total and free vinorelbine. In plasma, free vinorelbine has been shown to account for a small percentage of the total vinorelbine concentration.

About Alocrest(tm) (vinorelbine tartrate injection, OPTISOME(tm))
Alocrest is a novel sphingomyelin/cholesterol liposome-encapsulated vinorelbine formulation. Vinorelbine, a semi-synthetic vinca alkaloid, is a microtubule inhibitor that 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. In several countries, vinorelbine is also approved for the treatment of advanced stage breast cancer. Preclinical comparison data with Alocrest demonstrated improved pharmacokinetic properties, including an approximately 10-fold increase in preferential accumulation in tumors, and an improved therapeutic index.

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 Optisomal 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. 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.

The Hana Biosciences, Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3290

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, including Alocrest. 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.

SOURCE: Hana Biosciences, Inc.

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