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Biotech / Medical : Corixa [CRXA] - cancer vaccines -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (127)	1/15/2002 7:13:36 PM
From: SemiBull	Read Replies (2) \| Respond to of 222

Corixa to Present Melacine Data and Proposed Phase III Trial Design to the Oncologic Drugs Advisory Panel in February SEATTLE--(BW HealthWire)--Jan. 15, 2002--Corixa Corporation (Nasdaq:CRXA - news), a developer of immunotherapeutics, today announced it has been informed by the FDA that the Oncologic Drugs Advisory Committee (ODAC) will discuss the appropriate study design and control for a proposed second Phase III trial of Corixa's Melacine® melanoma vaccine at 12:30 p.m. 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 (SWOG). In October, 2001, Corixa announced that FDA approval of Melacine in the United States would require a second Phase III clinical trial in class I MHC HLA 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 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® adjuvant (monophosphoryl lipid A) and mycobacterial 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®, a monoclonal antibody conjugated to a radioisotope. 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. 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. -------------------------------------------------------------------------------- Contact: Corixa Corporation Jim DeNike, 206/754-5716 denike@corixa.com or FitzGerald Communications Jen Reinhard, 415/986-9500 jreinhard@fitzgerald.com