DEERFIELD, Ill., APRIL 24, 2013 - Baxter International Inc. (NYSE:BAX) today announced Phase I/II data evaluating the safety and immunogenicity of its investigational Lyme disease candidate vaccine during the National Foundation for Infectious Diseases 16th Annual Conference on Vaccine Research in Baltimore, Md. In this Phase I/II study, the candidate vaccine was shown to induce substantial antibody titers against all targeted species of Borrelia, the causative agent of Lyme disease, the most prevalent tick-transmitted disease, which is reported in the United States and throughout much of the European Union.
Baxter's Lyme disease vaccine was developed with a novel, multivalent chimeric antigen that targets specific immune functions and is designed to protect against the major species of Borrelia, the bacteria known to cause Lyme disease in Europe and the United States.
"Our candidate Lyme disease vaccine is a great example of innovation in exploring new ways to prevent disease through our vaccine technology," said Noel Barrett, Ph.D., vice president of research and development in Baxter's vaccines business. "Based on the results of this study, we are fully committed to further investigating the candidate vaccine in larger populations."
The phase I/II study evaluated the safety and immunogenicity of the vaccine at a range of antigen doses and formulations (either 30µg, 60µg or 90µg antigen), formulated with or without an adjuvant, an additive to stimulate immune response to the vaccine, in 300 healthy adults. Study participants received three primary immunizations and one booster immunization. The vaccine demonstrated predominantly mild adverse reactions and no vaccine-related serious adverse events. Substantial antibody titers were induced against all species of Borrelia targeted by the vaccine.
About Lyme Disease
Lyme disease is the most frequent tick-transmitted disease in the Northern Hemisphere and is associated with multiple clinical manifestations. Lyme disease is caused by Borrelia burgdorferi in the US and by multiple Borrelia species in Europe and Asia. No human vaccine is currently commercially available. Nearly 85,000 cases of Lyme disease are reported annually in Europe, and 30,000 cases in the United States. This number is expected to be largely underestimated as case reporting is highly inconsistent, and many infections go undiagnosed or are misdiagnosed.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning Baxter's investigational Lyme disease candidate vaccine and related clinical studies. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; additional clinical results; changes in laws and regulations; product quality or patient safety issues; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.