Corixa Provides Bexxar Regulatory Update.Business Editors, Health/Medical Writers BIOWIRE2K SEATTLE--(BW HealthWire)--Jan. 9, 2002 Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced that review by the Oncologic Drugs Advisory Committee (ODAC ODAC Old Dominion Athletic Conference ODAC Oracle Data Access Components ODAC Oil Depletion Analysis Centre ODAC Oncologic Drugs Advisory Committee ODAC Open Democracy Advice Centre ODAC Open Document Architecture Consortium ODAC Old Dominion Aquatic Club ) of the safety and efficacy of Bexxar(R) (tositumomab and iodine I 131 tositumomab), an investigational radioimmunotherapy being studied for the treatment of low-grade or transformed low-grade non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma , will not occur in February. Corixa stated that although it has been preparing for a February panel review, the U.S. Food and Drug Administration (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. ) has advised the company that, as a result of the extensive amount of material submitted in response to the agency's complete review letter and subsequent discussions, February would not be an optimal time for discussion at ODAC. Corixa further stated that the FDA has assured the company that it is continuing to work diligently on its review of Bexxar. The next ODAC meeting is tentatively scheduled for June 6-7, 2002, however the agenda has not been established by the FDA. Although Corixa can provide no assurances, the company is hopeful that the safety and efficacy of Bexxar will be reviewed at that time. Bexxar is being co-developed by Corixa and GlaxoSmithKline. "Corixa remains committed to Bexxar and the promise it holds as a potential therapeutic for non-Hodgkins lymphoma patients," stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "We will continue to assist the FDA in their ongoing review of our Biological License Application and look forward to ODAC review of our submission as soon as possible." About Corixa Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause , cancer and infectious diseases by understanding and directing the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . Corixa is focused on immunotherapeutic products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary product components on a stand-alone basis. Corixa currently has 16 programs in clinical development and 22 programs in preclinical development, including its most advanced product candidate, Bexxar(R), a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing conjugated conjugated adj. Conjugate. estrogens, conjugated Warning - Hazardous drug! C.E.S. to a radioisotope radioisotope: see radioactive isotope. Radioisotope (biology) A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes. . The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa(TM) technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, Washington, with additional operations in Hamilton, Montana and South San Francisco, California South San Francisco is a city in San Mateo County, California, United States, located on the San Francisco Peninsula in the San Francisco Bay Area. The population was 60,552 at the 2000 census. . For more information, please visit Corixa's Website at www.corixa.com or call the company's investor relations Investor relations The process by which the corporation communicates with its investors. information line at 1.877.4CORIXA or 877/426-7492. Forward Looking Statements Except for the historical information presented, certain statements in this press release relating to the FDA's approval of Bexxar are forward-looking statements. Forward-looking statements are based on the opinions and estimates of management at the time the statements are made. They are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Factors that could affect Corixa's actual results include, but are not limited to, the failure of FDA to approve the commercial sale of Bexxar, as well as the "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in Corixa's Quarterly Report on Form 10-Q for the quarter ended September 30, 2001, copies of which are available from Corixa's investor relations department. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. |
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