Abbott Laboratories and Corixa Corporation announced they have entered into an agreement under which Corixa granted to Abbott non-exclusive rights to Corixa's recombinant TcF antigen for potential use in the development of a blood screening test [assay] to detect antibodies to the parasite known as Trypanosoma cruzi (T.cruzi). T.cruzi causes Chagas' disease, a chronic, potentially lethal infection affecting a total of 16 million to 18 million people worldwide. The announced agreement is one of six agreements entered into between the two companies.

Chagas' disease primarily affects the nervous system and heart, causing severe neurological disorders as well as swelling or denervation of nervous tissue in the heart, colon and esophagus. The T.cruzi organism can circulate in the blood of afflicted individuals for many years after initial infection. Blood from an infected donor transfused into a recipient can lead to a transfusion-acquired infection. Blood banks have recognized the potential for introduction of T.cruzi into the US blood supply and have expressed an interest in the development and evaluation of tests that could be used to prevent its transmission.

"Abbott is developing a blood screening test that could help to protect the nation's blood supply against Chagas' disease," said Jim Koziarz, vice president, research and development, diagnostics, Abbott Laboratories. "Corixa's antigen has shown promise, and we look forward to further evaluating Corixa's technology as part of our development program."

In September 2002, Corixa presented evidence showing that its unique polyvalent antigen, known as TcF, may be useful for detecting the potential presence of T.cruzi. The potential test would detect serum antibody against the TcF antigen. This antibody to TcF would be expected to be detected only in those individuals previously exposed to T.cruzi.

"In studies to date, the TcF recombinant antigen has been able to detect nearly all patients infected with T.cruzi, and has avoided many of the problems of false positivity and unreliability associated with older assays that used whole organisms for antibody detection," said Steven Gillis, Ph.D., chairman and chief executive at Corixa. "Testing for this antibody could be considered in testing our nation's blood supply for this parasite."

Separate from the agreement for the T.cruzi antigen, Abbott and Corixa entered into five additional licensing agreements. Four agreements provide non-exclusive cross licenses to intellectual property owned by Abbott or Corixa, respectively, concerning two different cancer-associated antigens. In these agreements, Abbott received non-exclusive licenses from Corixa to develop certain diagnostic products and Corixa received non-exclusive licenses from Abbott to develop cancer vaccines and therapeutic drug monitoring products. In a separate agreement, Corixa granted Abbott non-exclusive rights to develop non-nucleic acid-based diagnostic assays intended to detect mammaglobin, a marker that appears to be significantly over-expressed in breast cancer.

All six agreements include payment of up-front fees, product development milestones and/or royalties on any product sales. Specific financial terms were not disclosed.

Chagas' disease often goes undiagnosed because its symptoms are also associated with heart disease and a variety of other disorders. In about one-third of acute cases, a chronic form of the disease develops some 10-20 years later, causing irreversible damage to the heart, esophagus and colon. Patients with severe Chagas' disease become progressively more ill and ultimately die, usually from heart failure. According to the World Health Organization, Chagas' disease is endemic in 21 countries, with 16 million to 18 million people infected and 100 million more at risk. Contaminated blood transfusions are suspected to be the primary way in which the parasite has been transmitted to industrialized countries.