SBIR-STTR Award

The overall goal is to develop antibody-based technology that can be used in consumer products for the prevention of sexual transmission of diseases (STDs). A small volume gel that provides 24 hours of STD protection could be used much like other consumer-based products that are used once a day or as needed. The well-established potency and specificity of antibodies make them ideal agents for discreet use by women or in combination with lubricants. The specific aims of this proposal are designed to determine the safety, efficacy and acceptability of antibody-based products. The proposed studies will: (a) measure the residence half time of a topically applied antibody in the human vagina; (b) develop the first human SIgA in a low cost, high capacity production system; (c) determine if anti-HSV2 plantibodies are stable in ex vivo secretions and are efficacious in vivo when used alone and when combined with a commercially available vaginal formulation and a sexual lubricant; (d) determine if mice absorb SIgA plantibodies by direct measurement of plantibodies in serum and indirectly by measurement of systemic and mucosal mouse anti-plantibody. PROPOSED COMMERCIAL APPLICATION: Antibody-based technology is now coming to fruition for systemic therapeutics, but an untapped commercial applications for antibodies are in mucosal prevention. Vaginal microbicides 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.

Thesaurus Terms:
antibody, antiviral antibody, biotechnology, communicable disease control, corn, herpes simplex virus 2, immunoglobulin A, mucosal immunity, sexually transmitted disease, vagina consumer product, gel, genital herpes, genital secretion, hybridoma, monoclonal antibody, passive immunization, protein engineering, safe sex, topical drug application bioengineering /biomedical engineering, clinical research, female, human subject, laboratory mouse

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. PROPOSED COMMERCIAL APPLICATION: 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.

Thesaurus Terms:
antiviral antibody, drug design /synthesis /production, drug screening /evaluation, herpes simplex virus 2, immunoglobulin A, immunologic preparation, sexually transmitted disease, topical drug application, transgenic plant clinical trial phase I, corn, drug adverse effect, gel, genital herpes, genital secretion, hybridoma, monoclonal antibody, passive immunization, plant extract, protein engineering, vagina biotechnology, clinical research, female, human subject, laboratory mouse, laboratory rabbit, laboratory rat