Corixa Announces the Initiation of Additional PVAC Treatment U.S. Clinical Trial
Randomized, Blinded and Controlled Trial to Evaluate Reduction in Disease Severity in Patients with Mild to Moderate Psoriasis
SEATTLE--(BW HealthWire)--June 6, 2002-- Corixa Corp. (Nasdaq:CRXA - News) today announced that it has initiated an additional U.S. clinical study designed to evaluate the potential effectiveness of PVAC(TM) treatment for patients with mild to moderate plaque psoriasis.
In this double-blind, randomized, placebo controlled study, patients with mild to moderate psoriasis will be randomized to one of four groups. Individual groups (approximately 60 patients each) will be treated with either placebo or one of three different dosages of PVAC treatment (2, 15, or 50 micrograms). Four doses will be given over a 15-week period with final efficacy evaluation to be conducted at 23 weeks. Efficacy endpoints will include improvements in disease severity as assessed by a decrease in baseline PASI (psoriasis area and severity index) scores. PVAC treatment or placebo will be administered via intradermal injection.
"This trial provides an excellent opportunity to continue our examination of the safety and efficacy of PVAC treatment in patients suffering from mild to moderate levels of psoriasis," stated Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "The initiation of this study is an important step in the potential development of PVAC treatment as a novel therapeutic for the management of psoriasis. It will allow us to expand our evaluation to different durations of therapy and will include patients who have not failed prior immunosuppressive therapies. The ability to expand our evaluation into patients with mild disease is based on the previously demonstrated benign safety profile of the therapy."
Patients have begun enrollment at fourteen clinical sites across the United States. Those interested in participating in this trial should contact Corixa's clinical trial information line at 206/754-5818 for further information.
Corixa, in collaboration with its partners -- Medicis, Zenyaku Kogyo Co. Ltd. and New Zealand-based Genesis Research and Development Corporation -- has developed PVAC as a product candidate for treatment of mild to moderate psoriasis. PVAC is a derivative of Mycobacterium vaccae and was produced for U.S. IND studies at Corixa's Hamilton, Montana facility.
About Psoriasis
According to the National Psoriasis Foundation, psoriasis is a chronic skin disease affecting more than seven million Americans, or about 2.6 percent of the U.S. population. Psoriasis occurs when new skin cells grow too rapidly, resulting in inflamed, scaly skin lesions. About 150,000 to 260,000 new cases of psoriasis are diagnosed each year. Annual outpatient costs for treating psoriasis are currently estimated at approximately $1.6 to $3.2 billion. Although the cause of psoriasis is unknown, researchers believe the increased activation, adhesion and passage of T-cells to the skin contributes to the inflammation and abnormal skin cell proliferation. Most current psoriasis therapies are palliative in nature and provide temporary patient benefit, or have significant side effects.
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 18 programs in clinical development.
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 statements in this press release relating to PVAC treatment 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 PVAC treatment to prove safe or efficacious in patients, 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 March 31, 2002, 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 Corp.
Jim DeNike, 206/754-5716
denike@corixa.com
or
Waggener Edstrom Bioscience
Colleen Beauregard, 503/443-7000
colleenb@wagged.com |
