Baxter Presents Phase I/II Data Evaluating Lyme Disease Vaccine at NFID
Annual Conference on Vaccine Research
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 16^th
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.
''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
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 U.S. and by multiple Borrelia
species in Europe and Asia. No human vaccine is currently commercially
available. More than 90,000 cases of Lyme disease are reported annually in
Europe, and 30,000 cases are reported annually in the U.S. 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
Baxter International Inc.
Brian Kyhos, (224) 948-4210
Mary Kay Ladone, (224) 948-3371
Clare Trachtman, (224) 948-3085
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