Corixa to Present Melacine Data and Proposed Phase III Trial Design to the Oncologic Drugs Advisory Panel in February.Business Editors, Health/Medical Writers SEATTLE--(BW HealthWire)--Jan. 15, 2002 Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced it has been informed 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. that 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 ) will discuss the appropriate study design and control for a proposed second Phase III trial of Corixa's Melacine(R) melanoma vaccine at 12:30 p.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT on February 27, 2002 in Bethesda, Maryland. Corixa's presentation to ODAC will include results from its completed first Phase III trial of Melacine vs. observation in patients with Stage II melanoma, as conducted by 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. (SWOG SWOG Southwestern Oncology Group ). In October, 2001, Corixa announced that FDA approval of Melacine in the United States would require 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 in class I MHC MHC major histocompatibility complex. MHC abbr. major histocompatibility complex MHC major histocompatibility complex. HLA HLA human leukocyte antigens. HLA abbr. human leukocyte antigen HLA (human leuckocyte antigen) A2 and C3 positive patients. In June 2001, Corixa announced the completion of a 17 month data sweep associated with the completed pivotal trial of Melacine vaccine for Stage II melanoma. In an effort to provide the FDA and its advisory panel reviewers with as up-to-date a data package as possible, Corixa committed to obtain additional mortality and disease recurrence data on as many patients as possible in the database, prior to proceeding with completion of a BLA BLA abbr. Bachelor of Liberal Arts filing. Re-analysis of overall disease free survival including these new data, showed that Melacine continues to provide an improvement in overall disease free survival, although the statistical significance of that conclusion was lost (p is greater than 0.05). However, analysis of clinical benefit following completion of the data sweep in patients who were positive for expression of either Class I MHC HLA A2 or C3 genes continued to show a highly statistically significant clinical benefit of Melacine vs. observation in terms of increased disease free survival (p=0.005). Furthermore, Corixa's analyses demonstrated a statistically significant improvement in overall survival in class I MHC HLA A2 or C3 positive patients that received Melacine vs. observation (p=0.003). About Melacine Melacine melanoma vaccine consists of lysed (broken) cells from two human melanoma cell lines combined with Corixa's proprietary Detox(TM) adjuvant. Detox adjuvant includes MPL 1. (language) MPL - An early possible name for PL/I. [Sammet 1969, p.542]. 2. MPL - MasPar data-parallel version of C. See also ampl. Compiler version 3.1. 3. MPL - Motorola Programming Language. (R) adjuvant (monophosphoryl lipid A) and mycobacterial mycobacterial emanating from or pertaining to mycobacterium. mycobacterial granuloma may be caused by Mycobacterium tuberculosis (see cutaneous tuberculosis), M. cell wall skeleton, both of which activate the human immune system in the context of vaccination. Melacine vaccine is administered as a two-shot vaccination delivered as four six-month cycles, each consisting of 10 treatments followed by a three-week rest. About Corixa Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune diseases, cancer and infectious diseases by understanding and directing the immune system. 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 conjugated 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 information line at 1.877.4CORIXA or 877/426-7492. Forward Looking Statements Except for the historical information presented, certain matters discussed in this press release relating to the development of our products 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 ODAC's failure to recommend that FDA approve Corixa's proposed Melacine trial design, Corixa's determination to not proceed with the trial even if design is recommended by ODAC and approved by FDA 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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