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8/17/2006
SOUTH SAN FRANCISCO, Calif., Aug 17, 2006 (BUSINESS WIRE) --
Hana Biosciences (NASDAQ:HNAB):
-- Trial Represents First Stage of Registration Program for Targeted Chemotherapy Agent
-- Multinational, Multicenter Phase III Randomized Trial in ALL to Commence before Year-End 2006
Hana Biosciences (NASDAQ:HNAB), a biopharmaceutical company focused on advancing cancer care, today announced the initiation of a multi-center Phase II clinical trial of Marqibo(R) (vincristine sulfate liposomes injection) in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). This study is designed to support a Phase III pivotal clinical trial of Marqibo for the treatment of ALL.
The primary objective of the Phase II open-label study is to assess efficacy of weekly doses of Marqibo plus pulse dexamethasone as measured by complete response rate. Secondary objectives are evaluation of safety and disease-free survival. This study is the Phase II portion of an ongoing Phase I/II clinical trial. Hana expects to enroll up to 44 patients in the Phase II Simon's two-stage designed clinical trial. Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt's subtypes) patients are eligible to enroll in the study.
"Adults with relapsed ALL have very few options for effective therapy. Several trials in lymphoproliferative malignancies including non-Hodgkin's lymphoma (NHL) and two Phase I trials in ALL have shown promising potential for Marqibo to improve clinical outcomes. This preliminary data supports moving this drug into pivotal trials," commented Dr. Greg Berk, Senior Vice President and Chief Medical Officer of Hana Biosciences.
Previous positive interim data from the Phase I clinical trial evaluating Marqibo in combination with dexamethasone in relapsed or refractory ALL was presented at the American Society of Hematology annual meeting in December 2004. The complete Phase I data is expected to be presented in the fourth quarter of 2006.
About Marqibo(R)
Marqibo utilizes vincristine encapsulated in a rigid, lipid bilayer of sphingomyelin. Vincristine is an FDA approved, standard chemotherapeutic used in most lymphoma and ALL regimens. It is a cell-cycle specific agent whose activity is dependent on the duration of drug exposure. The sphingosome encapsulated technology employed by Marqibo results in a liposome which is more rigid than conventional liposomes. Consequently, with Marqibo, the active vincristine leaks out of the liposome slowly and drug levels are maintained for prolonged periods of time. This improved pharmacokinetic profile of Marqibo, which mimics a continuous vincristine infusion, may result in greater activity in rapidly dividing cancers.
The anticipated activity associated with vincristine has traditionally been limited by its short half-life, and its inability to be dose escalated beyond 2mg due to neurotoxicity. In Phase I and II studies, Marqibo has shown to have a significantly longer half-life and patients have been able to tolerate doses which are 100 percent greater than conventional vincristine. These trials provide the rationale for utilizing this technology in lymphoproliferative diseases, such as ALL, Hodgkin's and non-Hodgkin's lymphoma.
This sphingosome encapsulated technology was discovered at the University of British Columbia and subsequently developed by Inex Pharmaceuticals Corporation. In May 2006, Hana Biosciences licensed from Inex the worldwide rights to three drug candidates utilizing this technology, including Marqibo.
About Acute Lymphoblastic Leukemia (ALL)
Approximately 4,000 cases of ALL are diagnosed annually in the United States. While cure rates for childhood ALL have steadily improved to nearly 90 percent, adult ALL reported cure rates seldom exceed 40 percent. The poorer outcome in adult ALL has been attributed to an increased frequency of high-risk leukemia with greater resistance, poorer tolerance of and compliance with treatment, reluctance to accept toxic effects, and less effective treatment regimens as compared with childhood ALL. Currently, there are no approved agents for ALL salvage, nor is there a consensus on the most appropriate regimen in the relapse setting. Ongoing efforts are needed to investigate agents for this indication, as well as incorporate active agents, once identified, into frontline therapy.
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 advance cancer care. The company is committed to creating value by building a world-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.
About Inex Pharmaceuticals Corporation
Inex Pharmaceuticals Corporation is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Since 1996, INEX common shares have been trading on the Toronto Stock Exchange under the symbol "IEX". Additional information on Inex Pharmaceuticals can be found at www.inexpharm.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 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 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 Marqibo and its product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Hana's product candidates, including Marqibo, the risk that the results of clinical trials may not support Hana's claims, 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, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
SOURCE: Hana Biosciences, Inc.
Hana Biosciences, Inc. Remy Bernarda, 650-228-2769 (Investor & Media Contacts) Fax: 650-588-2787 investor.relations@hanabiosciences.com
Copyright Business Wire 2006
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