Development of ColdSol TMfor Rhinovirus Infections

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DESCRIPTION (provided by applicant): The common cold is the most prevalent disease affecting humans, and 70% of cases are caused by rhinoviruses (HRV). The majority of HRV serotypes bind ICAM-1 on nasal epithelial cells as the initial step in the infectious cycle: therefore preventing HRV from binding to ICAM-1 should prevent HRV attachment and thereby either prevent or shorten the duration and decrease symptoms of existing colds. A human clinical trial using intranasal administration of an anti-ICAM whole antibody delayed the onset of colds by up to 2 days and decreased symptoms 50% but failed to prevent initial infection, It is now known that the antibody CAM-1 dissociation rate is similar to that of the HRV virion itself indicating that the antibody has no innate advantage in functional affinity over the virus in occupying available receptors. We have generated a tetravalent humanized antibody against ICAM-1 for the prevention and treatment of human rhinovirus (HRV) infections. This protein shows significant functional improvement over the monodonal antibody and it can be produced in bacteria at much lower cost. The goals of the proposed phase II study is to fully characterize the biological, physical and chemical properties of the tetravalent anti-ICAM antibody, optimize the production process, establish quality control assays and to optimize the nasal spray formulation. Result from these studies will support filing of IND to obtain approval from FDA for clinical trials.