The overall-goal is to develop plantibody-based microbicides that can be used in consumer products for the prevention of sexual transmission of diseases (STDs), as well as gastrointestinal and respiratory diseases. 'The potency and specificity of antibodies make them ideal agents for incorporation into a sexual lubricant. We have previously established (under SBIR Phase I support) that anti-HSV antibodies can be assembled in transgenic crops (rice and corn). This antibody was produced as a secretory IgA (sIgA) in order to provide enhanced structural stability. The demonstration of in vitro and in vivo efficacy of the plant-derived HSV8 sIgA establishes the feasibility of large scale production of topical antibodies in plants. The design directed specific aims of this Phase II proposal are to determine the safety, efficacy and acceptability of the HSV plantibody lubricant. specifically, the proposed studies will be to: (a) produce a HSV plantibody lubricant at GMP (b) evaluate toxicology in animals (c) evaluate safety in Phase I clinical trials (d) evaluate safety and surrogate efficacy in Phase I/II clinical trials.
Antibody-based technology is now coming to fruition for systemic therapeutics, but an untapped commercial applications for antibodies are in mucosal prevention. Vaginal rnicrobicides is one important application for mucosal antibodies but the technology is so flexible that it is readily extended to the prevention of diseases by pathogens at other mucosal sites.
