GlycoVaxyn initiates Phase I clinical trial for vaccine against Extra-intestinal pathogenic Escherichia coli

03-Jul-2014 - Switzerland

GlycoVaxyn AG announced the initiation of a Phase 1 clinical trial of a candidate vaccine to prevent infections caused by Extra-intestinal Pathogenic Escherichia coli (ExPEC), such as urinary tract infections (UTIs). The investigational vaccine is being co-developed by GlycoVaxyn AG and Janssen Pharmaceuticals Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

The first-in-human clinical study includes 180 women affected by recurrent UTI. It is a multicenter, placebo-controlled study conducted in Switzerland. The primary aim is to assess the safety of the candidate vaccine. In addition, the immunogenicity, measured by the induction of bactericidal (opsonophagocytic) antibodies, will be determined. Finally, the serotype-specific efficacy of the vaccine will be evaluated. The glycoconjugate ExPEC vaccine was produced using GlycoVaxyn's proprietary biological conjugation platform and contains surface polysaccharide antigens of the most predominant ExPEC strains.

Urinary tract infection (UTI) is the most common urological disease and one of the most frequent bacterial infections. Up to 50% of all women experience at least one UTI and 10-15% have recurrent UTI, which is a significant clinical problem in terms of morbidity, ongoing medical care, and associated health care costs. ExPEC bacteria cause 80% of community-acquired UTIs and approximately 50% of hospital-acquired UTIs. Increasing resistance to antibiotics among ExPEC strains thereby reducing the efficacy of treatment emphasizes the need to develop preventative measures.

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous

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Topic world Antibodies

Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous