Our passive immunity patent portfolio concerns the local or topical administration of monoclonal or polyclonal antibody compositions in the prevention and treatment of infectious disease.

This invention relates to compositions and methods for the local administration of human immunoglobulins (IgA, IgM, IgG), containing monoclonal or polyclonal antibodies, at a wound, surgical or burn site, or at a time of high risk of infection, in the prevention of bacterial and viral infections. Passive immunity involves the administration of immunoglobulin compositions containing sufficient antibodies to promote and augment host defenses prior to the onset of infection. In a series of in vitro and in vivo experiments, the inventors have demonstrated the ability of these compositions to inhibit or block adherence of invading infectious agents prior to the colonization and establishment of their own defenses (e.g., replication, biofilms, toxins, etc.). As a result, these compositions can reduce or eliminate the potential risk of infection. The immunoglobulin compositions of this invention can be supplemented with polyclonal or monocolonal antibodies specific for the elimination of a bacterial or viral agent. Novel animal or plant-plant based expression systems may prove useful for the production of larger quantities of mono- or polyclonal antibodies. These compositions may be applied directly to a wound or burn site (e.g., ointment, crème, fluid, spray, etc), be bound to biocompatible materials for use in situ (e.g., lozenge, bandage, etc.), or be formulated in coatings for surfaces in direct contact with blood, other body fluids, or tissues (e.g, catheters, implantable devices). Applications of this invention include the development of anti-infective therapies capable of reducing inflammatory tissue damage and the rejection of biomaterials and transplants due to infection. Anti-infective therapies specific for antibiotic resistant strains of microorganisms can be developed to complement existing antibiotic therapies while addressing the problem of increased antibiotic resistance.

Market Opportunity:
A clear need exists from a human health perspective to discover and develop new approaches of protecting individuals against evolving pathogenic threats and challenges. Infectious diseases are the leading cause of mortality and morbidity in the world and the third-leading cause of death in the United States. Greater than 2 million cases of hospital-acquired infections are reported each year within the United States resulting in some 88,000 deaths. The Centers for Disease Control and Prevention (CDC) have suggested that infections acquired while in hospital for other health problems add almost $5 billion/year to the total cost of providing health care. The extensive use of antibiotic therapies in fighting infections has contributed to resistance within an increasing number of disease causing micro-organisms. Estimates of the total costs for managing antibiotic resistance within the United States range from $0.1 to 10 billion per year. The overall market for anti-infective drug products is greater than $20 billion. Given the availability of other anti-infectives and treatments in pre-clinical and clinical development, the value of the market opportunity for development of a new anti-infective therapy based on these compositions is anticipated to be $500 million/year. The worldwide sales for some of the most successful anti-infective therapies are in excess of $1 billion/year.