Hana Biosciences Initiates Marqibo(R) Phase II Clinical Trial in Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL).SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif. -- Hana Biosciences (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :HNAB): --Trial Represents First Stage of Registration Program for Targeted Chemotherapy Agent --Multinational, Multicenter Phase III Randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. 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 Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of Marqibo(R) (vincristine sulfate liposomes Liposomes Aqueous compartments enclosed by lipid bilayer membranes; liposomes are also known as lipid vesicles. Phospholipid molecules consist of an elongated nonpolar (hydrophobic) structure with a polar (hydrophilic) structure at one end. injection) in patients with relapsed or refractory acute lymphoblastic leukemia acute lymphoblastic leukemia n. Abbr. ALL Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic 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 dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the 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 NHL Non-Hodgkin's lymphoma, see there ) 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 Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I 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 vincristine /vin·cris·tine/ (vin-kris´ten) an antineoplastic vinca alkaloid; used as the sulfate salt in the treatment of various neoplasms, including Hodgkin's disease, acute lymphocytic leukemia, non-Hodgkin's lymphoma, Kaposi's encapsulated in a rigid, lipid bilayer of sphingomyelin sphingomyelin /sphin·go·my·elin/ (-mi´e-lin) any of the sphingolipids in which the head group is phosphorylated choline; they occur in membranes, primarily in nervous tissue, and accumulate abnormally in Niemann-Pick disease. . Vincristine is an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes. 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 neurotoxicity /neu·ro·tox·ic·i·ty/ (noor?o-tok-sis´it-e) the quality of exerting a destructive or poisonous effect upon nerve tissue. . 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 Locations Vancouver The Vancouver campus is located at Point Grey, a twenty-minute drive from downtown Vancouver. It is near several beaches and has views of the North Shore mountains. The 7. 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 Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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