Chiron and XOMA Announce Initiation of Phase I Clinical Trial for CHIR-12.12 in Multiple Myeloma -- Second Clinical Trial Evaluating Oncology Drug Candidate Begins.EMERYVILLE, Calif. & BERKELEY, Calif. -- Chiron Corporation (Nasdaq:CHIR CHIR Chiricahua National Monument (US National Park Service) ) and XOMA Ltd. (Nasdaq:XOMA) today announced the initiation of a second clinical trial of CHIR-12.12, a novel, fully human, antagonist antibody that targets the CD40 antigen. The Phase I trial is for patients with multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility , a type of cancer that is associated with expression of the CD40 antigen on the cancer cell surface. Chiron and XOMA announced the initiation of a 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 of CHIR-12.12 in patients with chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. in April 2005. CHIR-12.12 is the first drug candidate to enter clinical testing under the collaborative agreement between Chiron and XOMA for the development and commercialization of antibody products for the treatment of cancer. "The expansion of our Phase I program is an indication of our excitement for this compound," said Stephen Dilly dil·ly n. pl. dil·lies Slang One that is remarkable or extraordinary, as in size or quality: had a dilly of a fight. , M.D., Ph.D., chief medical officer, Chiron BioPharmaceuticals. "Chiron's translational-medicine approach to drug development has helped identify diseases against which CHIR-12.12 may be effective, providing us with data that supports our decision to move forward with studies in multiple areas." "We're pleased to move CHIR-12.12 into clinical studies in a second B-cell oncology indication," said John C. Castello, XOMA's chairman, president and chief executive officer. "Our collaboration with Chiron enables both companies to advance promising antibodies more quickly than either could alone. This benefits our employees and shareholders, as well as potentially offering a new treatment for multiple myeloma patients." The single-agent, open-label Phase I study of CHIR-12.12 is designed to evaluate the safety, dose tolerability and pharmacokinetic profile of CHIR-12.12 in patients with multiple myeloma. Translational medicine translational medicine Molecular medicine The constellation of activities which seek to translate the science of gene discovery, gene transfer, and functional genomics into gene-targeted therapies will be used to monitor biomarkers and allow correlation of these markers with response to CHIR-12.12 therapy, guiding the dosing regimen and the selection of responsive patient populations. The study is expected to enroll up to 40 patients at four leading cancer centers in the United States. About CHIR-12.12 CHIR-12.12 is a fully human, antagonist antibody that targets the CD40 antigen. As shown in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. in cell lines, in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. in animal models and ex vivo ex vivo /ex vi·vo/ (eks´ ve´vo) outside the living body; denoting removal of an organ (e.g., the kidney) for reparative surgery, after which it is returned to the original site. in patient cells, CHIR-12.12 binds to tumor cells that express CD40 and antagonizes (prevents) CD40 ligand-mediated growth and survival of malignant B cells. Based on preclinical data, CHIR-12.12 also induces antibody-dependent cellular cytotoxicity (ADCC ADCC antibody-dependent cell-mediated cytotoxicity. ADCC antibody-dependent cell-mediated cytotoxicity. ), killing CD40 expressing tumor cells by immune effector cells. This dual mechanism of action makes CHIR-12.12 a drug candidate with potential for the treatment of B-cell malignancies. CHIR-12.12 is an investigational drug candidate and has not been approved by the U.S. Food and Drug Administration. About Multiple Myeloma Multiple myeloma, also known as myeloma myeloma /my·elo·ma/ (mi?e-lo´mah) a tumor composed of cells of the type normally found in the bone marrow. giant cell myeloma see under tumor (1). or plasma cell myeloma plasma cell myeloma n. A malignant plasmacytoma of bone. , is a progressive hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. (blood) cancer of the plasma cell plasma cell n. An antibody-producing lymphocyte derived from a B cell upon reaction with a specific antigen. Also called plasmacyte. Plasma cell (a type of B lymphocyte B lymphocyte or B-lymphocyte n. See B cell. B lymphocyte A type of lymphocyte that circulates in the blood and lymph and produces antibodies when it encounters specific antigens. ), an important part of the immune system that produces immunoglobulins (antibodies) to help fight infection and disease. Clinical manifestations of multiple myeloma include hypercalcemia Hypercalcemia Definition Hypercalcemia is an abnormally high level of calcium in the blood, usually more than 10.5 milligrams per deciliter of blood. , anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulin. The disease also is characterized by diffuse osteoporosis (bone destruction), usually in the pelvis, spine, ribs and skull. Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma, representing approximately 1 percent of all cancers and 2 percent of all cancer deaths. The median age at diagnosis is about 71 years, and only 2 percent of cases are diagnosed in individuals under the age of 45. Statistics indicate both increasing incidence and earlier age of onset The age of onset is a medical term referring to the age at which an individual acquires, develops, or first experiences a condition or symptoms of a disease or disorder. Diseases are often categorized by their ages of onset as congenital, infantile, juvenile, or adult. of multiple myeloma. Approximately 50,000 Americans currently have multiple myeloma, and the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, estimates that approximately 15,980 new cases of multiple myeloma will be diagnosed in 2005. About Chiron Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information, please visit www.chiron.com. About XOMA XOMA develops and commercializes antibody and other protein-based biopharmaceuticals for cancer, immune disorders and infectious diseases. The company pipeline includes products from collaborative product development Collaborative Product Development (Collaborative Product Design) (CPD) is a business strategy, work process and collection of software applications that facilitates different organizations to work together on the development of a product. programs with Chiron Corporation, Millennium Pharmaceuticals, Inc., and Aphton Corporation, and also includes RAPTIVA(R), a product marketed worldwide that came from a collaboration with Genentech, Inc. For more information about XOMA's product pipeline and antibody product development capabilities and technologies, please visit XOMA's website at www.xoma.com. Chiron Forward-Looking Statements This news release contains forward-looking statements, including statements regarding development of CHIR-12.12, regulatory review and marketing, that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the Form 10-Q for the quarter ended June 30, 2005, and the Form 10-K for the year ended December 31, 2004, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review and approvals, competition, manufacturing capabilities, intellectual property protections and defenses, and marketing effectiveness. In particular, there can be no assurance that Chiron will successfully develop and receive approval to market new products, including CHIR-12.12, or achieve market acceptance for such new products. There can be no assurance that Chiron's out-licensing activities will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties. In addition, the company may engage in business opportunities, the successful completion of which are subject to certain risks, including approval by Novartis AG, regulatory approvals, and the integration of operations. We do not undertake an obligation to update the forward-looking information we are giving today. XOMA Forward-Looking Statements Statements made in this press release related to progress or timing of product development or collaborative arrangements, or that otherwise relate to future periods, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These risks, including those related to the results of pre-clinical testing, the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by 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. , European or other regulators, their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data), changes in the status of existing collaborative relationships, the ability of collaborators and other partners to meet their obligations, market demand for products, scale up and marketing capabilities, competition, availability of additional licensing or collaboration opportunities, international operations, share price volatility, XOMA's financing needs and opportunities, uncertainties regarding the status of biotechnology patents, uncertainties as to the cost of protecting intellectual property and risks associated with XOMA's status as a Bermuda company, are discussed in the Company's most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in evaluating XOMA's prospects. |
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