Hana Biosciences Announces Top-Line Phase 1 Clinical Trial Data Demonstrating Alocrest to be Well-Tolerated With Promising Anti-Tumor Activity
SOUTH SAN FRANCISCO, Calif., Feb. 12, 2008 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the company has completed patient enrollment in its Phase 1 dose-escalation clinical trial of Alocrest(tm) (vinorelbine liposomes injection, Optisome. This trial was designed to assess the safety, tolerability and preliminary efficacy of Optisomal encapsulated vinorelbine, or Alocrest. Preliminary results show that Alocrest was generally well tolerated with acceptable and predictable toxicities and had a maximum tolerated dose comparable to that of un-encapsulated vinorelbine. In this first human study of Alocrest, the drug produced a disease control rate of 46 percent across a broad range of doses and tumor types. Hana Biosciences anticipates submitting these data for presentation at a major medical conference in Europe this summer.
"We are pleased to have achieved this milestone in the clinical development of our second Optisome-encapsulated product candidate. In this Phase 1 clinical trial, Alocrest was well-tolerated and showed promising anti-tumor activity with no new toxicity relative to conventional vinorelbine," said Steven R. Deitcher, M.D., President and CEO of Hana Biosciences. "We are also encouraged to see such positive response data in heavily pre-treated patients. With these data in hand, we believe we are well positioned to seek out an enthusiastic partner with whom we can advance Alocrest as we focus our near-term efforts on the clinical development of Marqibo and Menadione."
The Phase 1 clinical trial enrolled 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. Patients received Alocrest via a 60-minute IV infusion on days 1 and 8 every 21 days at various dose levels. Reversible neutropenia was the most common dose limiting toxicity. The study was conducted at the Cancer Therapy and Research Center and the START facility in San Antonio and McGill University, Montreal.
About Alocrest(tm) (vinorelbine liposomes injection, OPTISOME(tm))
Alocrest is a novel sphingomyelin/cholesterol liposome-encapsulated vinorelbine tartrate 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 outside the United States, 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 to improve efficacy and reduce 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. 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 timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings and commercialization and partnering efforts relating to Hana's product candidates, including its Alocrest product candidate. 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, that the results of clinical trials will support Hana's claims or beliefs concerning the effectiveness of its product candidates and that Hana will be able to successfully partner with another company to develop Alocrest. 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-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.
CONTACT: Hana Biosciences, Inc. Investor & Media Contacts: Remy Bernarda, Director, Investor Relations (650) 228-2769 Fax (650) 588-2787 firstname.lastname@example.org
Posted: February 2008