Seattle, US and Rixensart, Belgium, January 14, 2004 - Corixa Corp. (Nasdaq: CRXA), a developer of immunotherapeutics, and GlaxoSmithKline Biologicals (GSK Bio) one of the world's leading vaccine companies, today announced that the FDA is allowing the initiation of a Phase I clinical study to evaluate the safety and immunogenicity of a novel, proprietary prophylactic vaccine designed to induce protection against tuberculosis (TB). The trial will be conducted in the United States under the Investigational New Drug Application (IND), currently held by Corixa and will be the first study of this TB vaccine to be conducted in human volunteers.
The vaccine combines a proprietary, recombinant tuberculosis protein antigen and a GSK Bio proprietary formulation that incorporates several adjuvants including Corixa's MPL ® adjuvant. MPL is Corixa's flagship adjuvant, which is present in multiple GSK Bio vaccines now in late stage clinical development. The recombinant tuberculosis antigen is a fusion protein of antigenic domains taken from different Mycobacterium tuberculosis gene products that are recognized by immune system cells harvested from patients that had been infected with tuberculosis but who never showed signs of disease. The fusion protein adjuvant combination appears to have demonstrated protection against tuberculosis infection in a number of relevant animal species including mice, guinea pigs and monkeys.
The vaccine is the first recombinant tuberculosis protein vaccine ever to be tested in humans and is the result of a long-standing collaboration between GSK Bio and Corixa to develop vaccines for certain infectious diseases.
"Tuberculosis represents a significant global public health problem," said Jean Stephenne, President of GlaxoSmithKline Biologicals. "We believe that a recombinant tuberculosis vaccine holds great promise for protection of patients around the world against TB and we look forward to the initiation of the clinical program for this vaccine."
"This trial initiation underscores the productivity of our development partnerships with GSK Bio," said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "Pursuing the clinical development of novel vaccines that contain both proprietary antigens and adjuvants from our discovery pipeline remains a key area of growth for Corixa. We look forward to the continued progress of the TB vaccine program in 2004."
About the Trial
The trial will enroll 20 volunteers at one clinical centre in the United States. The trial will be a standard dose escalation study in which different cohorts of patients receive escalating doses of recombinant vaccine together with a constant dose of adjuvant. Patients will be evaluated for safety, and serum and immune cells will be collected post-vaccination to determine which dose of vaccine promotes the greatest anti-TB immune response.
About Tuberculosis
Mycobacterium tuberculosis, or Mtb, infection causes more deaths than any other infectious disease in the world. According to the World Health Organization (WHO), each year approximately 8 million people worldwide become sick with tuberculosis and an estimated 2 million die annually from the disease. The WHO estimates that between the years 2000 and 2020 nearly 1 billion people will be newly infected with Mtb, 150 million people will get sick and 36 million will die. According to the National Institute of Allergy and Infectious Diseases, an estimated 2 billion people are infected with Mtb, including approximately 15 million people in the United States. The WHO estimates that up to 50 million persons worldwide may be infected with drug resistant strains of Mtb.
About GlaxoSmithKline Biologicals
GlaxoSmithKline Biologicals (GSK Biologicals), one of the world's leading vaccine companies, is located in Rixensart, Belgium. Belgium is the centre of all GlaxoSmithKline's activities in the field of vaccine research, development and production. GSK Biologicals employs more than 1000 research scientists who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. Last year, an average of 25 GSK Biologicals vaccine doses per second were delivered to 156 countries in both the developed and developing world. 100 million of the 800 million plus vaccine doses delivered last year were combined paediatric vaccines that protect the world's children against a minimum of 3 and up to 6 diseases. For information, visit GSK Biologicals' vaccines website site at www.gsk-bio.com GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
About Corixa
Corixa is a developer of immunotherapeutics with a commitment to treating and preventing cancer and infectious diseases by understanding and directing the immune system. On June 30, 2003, Corixa announced that the FDA approved BEXXAR for the treatment of patients with CD20-positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.
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. In addition to BEXXAR , Corixa currently has multiple programs in clinical development, including several product candidates that have advanced to and through late stage clinical trials. The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa® 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, with additional operations in Hamilton, Mont., and South San Francisco. For more information, please visit Corixa's Web site at www.corixa.com.
Corixa Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding our plans, objectives, intentions and expectations. 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 risk that the collaboration does not result in any commercial products, and the "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in our Quarterly Report on Form 10-Q for the quarter ended Sept. 30, 2003, copies of which are available from our 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.
For more information:
Corixa Investor Relations
Jim DeNike
Corixa Corp.
+1 206 754-5716
denike@corixa.com
Corixa Media Relations
Colleen Beauregard
Waggener Edstrom Bioscience
+ 1 503 443-7000
colleenb@wagged.com
GSK Biologicals:
Stephanie Tortell
GSK Biologicals
+32 2 656 9832
stephanie.tortell@gskbio.com
