Hana Biosciences Completes Licensing of Three Targeted Cancer Drug Candidates from Inex Pharmaceuticals.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): --Hana Plans to Initiate Pivotal Trials for Marqibo(R) (vincristine sulfate vin·cris·tine sulfate n. The sulfate salt of a dimeric alkaloid obtained from a plant of the genus Vinca that exhibits antineoplastic activity similar to that of vinblastine sulfate and is used especially in the treatment of lymphocytic ) 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 Hematological Malignancies in 2006. --Sphingosome Encapsulated Vinorelbine Targeted to Start Clinical Trials in 2006, and Sphingosome Encapsulated Topotecan in 2007. --Proprietary Sphingosomal Platform Doubles Hana's Oncology Pipeline to Six Clinical Stage Drugs. Hana Biosciences (NASDAQ:HNAB), a biopharmaceutical company focused on advancing cancer care, completed its previously announced licensing transaction with Inex Pharmaceuticals Corporation (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :IEX IEX Ion Exchange (chromatography) IEX Inter-Exchange Carrier ). Under the terms of the transaction, Hana paid INEX a total of $11.5 million, consisting of cash and shares of Hana common stock. In addition, Hana will pay INEX up to $30.5 million in shares of Hana common stock, contingent upon achievement of specific clinical and regulatory milestones, as well as royalties on net sales. Canaccord Adams acted as the exclusive financial advisor to Hana in the transaction. This licensing transaction doubled Hana's pipeline to six clinical-stage oncology compounds. The newly-licensed drug candidates are: --Marqibo(R) (vincristine sulfate) Liposomes Injection, a sphingosome encapsulated vinorelbine, which has shown promising results in patients with non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ) and acute lymphocytic leukemia acute lymphocytic leukemia n. See acute lymphoblastic leukemia. acute lymphocytic leukemia Acute lymphoblastic leukemia, ALL A malignant lymphoproliferative process that commonly affects children and young adults (ALL) in completed and ongoing studies. After a Special Protocol Assessment (SPA) is completed with the 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. , Hana expects to commence pivotal trials in Marqibo(R) in 2006. --Sphingosome encapsulated vinorelbine, for which a US Investigational New Drug (IND) application and Canadian Clinical Trials Application (CTA An abbreviation for cum testamento annexo, Latin for "with the will annexed." ) have been accepted, is planned to enter clinical trials in 2006. --Sphingosome encapsulated topotecan, based on a unique formulation which has shown significantly enhanced activity in pre-clinical models, is planned to enter clinical trials in 2007. The intellectual property covering the three product candidates is protected worldwide until 2020 by issued and pending patents. "This transaction enhances Hana's portfolio of novel anticancer compounds, underscoring our patient-focused commitment to developing and commercializing innovative oncology therapies. We look forward to working with the FDA to obtain an SPA to initiate pivotal trials for Marqibo(R) in 2006. Meanwhile, our current clinical programs continue on schedule," said Mark Ahn, PhD, Hana's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . Timothy M. Ruane, President and CEO of INEX, stated: "The team at Hana has a strong track record in oncology drug development, and we believe our targeted chemotherapy products are a perfect fit in their pipeline. We will support their efforts as they move Marqibo(R) towards commercialization and continue the development of sphingosomal vinorelbine and sphingosomal topotecan." "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 is a cornerstone of combination chemotherapy in lymphoproliferative diseases. We believe that by raising the dose of this drug we can improve its clinical activity. The increased dose and promising activity of sphingosomal vincristine in patients with NHL and ALL support moving this drug into registrational trials", said Dr. Hagop Kantarjian, MD, Professor and Chairman of the Leukemia Department at the M.D. Anderson Cancer Center. About Sphingosomal Targeted Drug Delivery Scientists began to study targeted drug delivery, because the traditional drug delivery system had many disadvantages, such as high toxic effect and high minimum effective dose. In traditional drug delivery system, after the patient takes some drugs, the drugs will be all over his body Sphingosomal encapsulation is a new generation liposomal drug delivery platform, which is designed to significantly increase tumor targeting and duration of exposure for cell cycle-specific anticancer agents. Sphingosomal drug delivery consists of encapsulating an already approved cancer agent in a lipid envelope. The encapsulated agent is carried through the bloodstream and delivered to disease sites where it is released to carry out its therapeutic action. When used in unencapsulated form, chemotherapeutic drugs diffuse indiscriminately throughout the body, diluting drug effectiveness and causing toxic side effects in the patient's healthy tissues. The proprietary sphingosomal formulation technology permits the loading of a high concentration of therapeutic agent inside the lipid envelope, promotes accumulation of the drug in tumors and prolongs the release of the drug at disease sites. As a result, compared to unencapsulated drugs, agents encapsulated in sphingosomes have been shown in preclinical models to deliver more of the therapeutic agent to a targeted disease site over a longer period of time, thus potentially increasing the efficacy of the drug without increasing the toxicity in healthy, non-targeted tissues. The possible advantages of sphingosomal drug delivery include: --Longer circulation time in plasma delivers more of the therapeutic agent to targeted tumor sites over a longer period of time. To stabilize the lipid bilayer walls and retain active drug within the aqueous interior, this new generation liposomal technology uses 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. , a safe, biologically inert macromolecule macromolecule, term that may refer either to a crystal such as a diamond, in which the atoms are identical and held by covalent bonds (see chemical bond) of equal strength, or to one of the units that compose a polymer. whose amide backbone is resistant to hydrolysis hydrolysis (hīdrŏl`ĭsĭs), chemical reaction of a compound with water, usually resulting in the formation of one or more new compounds. . The increased rigidity of the liposomal walls prolongs the circulating life of liposomes and significantly extends the duration of drug release. --Sphingosomal drugs like Marqibo(R) readily extravasate ex·trav·a·sate v. To exude from or pass out of a vessel into the tissues. Used of blood, lymph, or urine. ex·trav through the pores of leaky tumor vessels created during angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. and readily accumulate within the tumor. In normal tissues, a continuous endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium. Endothelial A layer of cells that lines the inside of certain body cavities, for example, blood vessels. lining constrains liposomes within capillaries, preventing accumulation of the drug in the interstitial space. In contrast, the immature neovasculature within tumors is created during angiogenesis and has numerous imperfections, pores and discontinuities up to 800 nm in size. With an average diameter of approximately 100 nm, sphingosomes readily extravasate through these pores and accumulate within the tumor. Once lodged within the interstitial space, these resilient sphingosomes slowly release the encapsulated drug. Slow release of the drug from extravasated sphingosomes increases drug levels within the tumor, extends drug exposure through multiple cell cycles, and significantly enhances tumor cell killing. Vincristine kills tumor cells as they pass through a sensitive phase of cell division, but fewer than 5% of a patient's tumor cells are in this sensitive phase at any point in time. We believe that the duration of drug exposure is therefore critical to increased clinical activity. --Increased drug concentration at the tumor site is associated with increased clinical activity. The link between drug exposure and anti-tumor efficacy is especially pronounced for cell cycle-specific agents such as vincristine, vinorelbine and topotecan, which kill tumor cells by interfering with mitosis at a precise step during the cancer cell cycle. Thus, this proprietary sphingosomal drug delivery platform encapsulates approved anticancer agents within the aqueous interior of small liposomes to potentially enhance the therapeutic index of these existing anticancer treatments. About Vincristine, Vinorelbine, and Topotecan Sphingosomal products, such as Marqibo(R) (vincristine sulfate) Liposomes Injection, are loaded with active, cell cycle-specific anticancer agents that may benefit from increased targeting and long duration of drug exposure at the tumor site. Vincristine, vinorelbine and topotecan are approved cancer therapies which have been selected for sphingosomal formulation specifically for their ability to benefit from this novel encapsulation: --Vincristine (Oncovin(R); Eli Lilly & Company), a microtubule microtubule Tubular structure enclosed by a membrane found within animal and plant cells. Of varying length, they have several functions. They help give shape to many cells and are major components of cilia and flagella, participate in the formation of the spindle during inhibitor, is approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. --Vinorelbine (Navelbine(R); GlaxoSmithKline), a microtubule inhibitor, is approved for use as a single agent or in combination with cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic. cis·plat·in n. for the first-line treatment of unresectable, advanced non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. . --Topotecan (Hycamtin(R); GlaxoSmithKline), a topoisomerase topoisomerase an enzyme involved in DNA replication that introduces a single-strand nick in the DNA enabling it to swivel and thereby relieve the accumulated winding strain generated during unwinding of the double helix. I inhibitor, is approved for use in relapsed small-cell lung cancer and in relapsed ovarian cancer. About Non-Hodgkin's Lymphoma (NHL) and Acute Lymphocytic Leukemia (ALL) NHL is a heterogeneous disease which results in approximately 50,000 new cases and almost 25,000 deaths annually in the United States. NHL usually originates in lymphoid tissues and can spread to other organs. The prognosis depends on the histologic type, stage, and treatment. The NHLs can be divided into 2 prognostic groups: indolent lymphomas and aggressive lymphomas. Indolent indolent /in·do·lent/ (in´dah-lint) 1. causing little pain. 2. slow growing. in·do·lent adj. 1. Disinclined to exert oneself; habitually lazy. 2. NHL types have a relatively good prognosis, with median survival as long as 10 years, but they usually are not curable cur·a·ble adj. Capable of being cured or healed. in advanced clinical stages. The aggressive type of NHL has a shorter natural history, but a significant number of these patients can be cured with intensive combination chemotherapy regimens which include agents such as vincristine. With modern treatment, overall five-year survival of NHL patients is approximately 50% to 60%. Of patients with aggressive NHL, 30% to 60% can achieve durable remission. The vast majority of relapses occur in the first two years after therapy and new therapeutic options are needed. ALL is a type of blood and bone marrow cancer -- the spongy spongy /spon·gy/ (spun´je) of a spongelike appearance or texture. spong·y adj. Resembling a sponge in appearance, elasticity, or porosity. tissue inside bones where blood cells are made. Acute leukemias progress rapidly and affect immature blood cells, rather than mature ones. Acute lymphocytic leukemia affects a group of white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies called lymphocytes, which fight infection. Normally, bone marrow produces immature cells (stem cells) in a controlled way, and they mature and specialize into the various types of blood cells, as needed. In people with ALL, this production process goes awry. Large numbers of immature, abnormal lymphocytes called lymphoblasts are produced and released into the bloodstream. These abnormal cells are not able to mature and perform their usual functions. Furthermore, they multiply rapidly and can crowd out healthy blood cells, leaving an adult or child with ALL vulnerable to infection or easy bleeding. Leukemic cells can also collect in certain areas of the body, including the central nervous system and spinal cord, which can cause serious problems. Almost 4,000 Americans are diagnosed with ALL each year. This form of cancer worsens quickly if not treated, but it usually responds well to initial treatment. Adults have a 20% to 40% cure rate, underscoring the need for new therapeutic options. About Hana Biosciences, Inc. Hana Biosciences, Inc. (NASDAQ:HNAB) is a South San Francisco, CA-based biopharmaceutical company that acquires, develops, and commercializes 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 its product candidates, including those licensed from INEX, 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, 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 Annual Report on Form 10-K for the year ended December 31, 2005 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion