Oncologic Drugs Advisory Committee Endorses Corixa's Phase III Trial Design for Melacine Melanoma Vaccine.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE--(BW HealthWire)--Feb. 28, 2002 Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced 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 ) has endorsed Corixa's proposed design for a second Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for its melanoma vaccine, Melacine(R), following the company's presentation to the panel on February 27, 2002 in Bethesda, Maryland. Corixa proposed a trial design that would evaluate Melacine vaccine vs. observation in HLA HLA human leukocyte antigens. HLA abbr. human leukocyte antigen HLA (human leuckocyte antigen) A2 and/or HLA C3 positive, Stage II melanoma patients following surgery. Corixa presented results from the Southwest Oncology Group The Southwest Oncology Group (SWOG) is a National Cancer Institute (NCI) sponsored organization that conducts clinical trials in adult cancers. SWOG was created by the NCI in 1956, and its was headquartered in Houston, Texas. trial (SWOG-9035) that demonstrated Melacine vaccine was effective in prolonging relapse-free survival (p=0.005) and overall survival (p=0.003) compared to observation in patients who expressed HLA A2 and/or HLA C3. The panel agreed that the proposed second Phase III trial, with overall survival as the primary endpoint, in addition to the supportive data from the first Phase III trial (SWOG-9035), would be acceptable for approval of Melacine vaccine. "We are encouraged by ODAC's support of the data we presented and our current plans for a second Melacine Phase III trial," said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "We will work diligently 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. and national cooperative study groups to finalize this protocol and will continue to provide periodic updates as events warrant." 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 standalone basis. Corixa currently has 16 programs in clinical development and 22 programs in preclinical development, including its most advanced product candidate, Bexxar(TM), for the treatment of 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 . 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 Web site 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 877/4CORIXA or 877/426-7492. Forward-Looking Statements Except for the historical information presented, certain matters discussed in this press release 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, a decision by Corixa not to proceed with the planned Phase III trial, FDA's failure to approve Melacine for commercial sale even if Corixa obtains positive data from the planned Phase III trial, and 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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