SBIR-STTR Award

We will develop a commercially available vaginal suppository containing a hydrogen peroxide-producing strain of Lactobacillus for use in colonization of the vagina. In this project, a strain of Lactobacillus will be identified based on adherence to vaginal epithelial cells, hydrogen peroxide production, and growth characteristics. Methods for strain preservation and maintenance of viability, biochemical, physiologic and genetic characteristics during large scale production will be optimized. The effect of suppository delivery formats and components including various cream and gel bases, growth or nutritional additives on successful bacterial rejuvenation, adherence and hydrogen peroxide production will be investigated.Awardee's statement of the potential commercial applications of the research:A commercial suppository capable of re-establishing the optimal vaginal ecosystem could decrease occurrence of genital tract infections. There are 57.4 million women of child-bearing age (15-44 years old) in the US. Only half of these women are colonized with H202-producing lactobacill i, a primary defense mechanism against genital infections. The commercial need is evidenced by the estimated 10 million annual of fice visits for vaginal compTaints each year.National Institute of Allergy and Infectious Diseases (NIAID)

The goal of this project is to develop a commercially available vaginal suppository containing a H2O2-producing strain of Lactobacillus for use in colonization of the vagina. Vaginal lactobacilli are the primary microbial defense against infection. Lactobacillus predominant vaginal flora is associated with decreased frequencies of gonorrhea and chlamydial infections. Women with H2O2-producing lactobacilli have fewer vaginal infections including bacterial vaginosis and trichomoniasis. While only half of women of child-bearing age are colonized by H2O2-producing lactobacilli, there are no commercially available products in the U.S. suitable as vaginal suppositories. During Phase I studies, a strain of Lactobacillus was selected based on adherence to vaginal epithelial cells, H2O2-production, growth characteristics and viability stability during storage. Pilot production methols to preserve these characteristics in a suppository format were developed. In this study, commercial scale cGMP production and packaging methods for the suppository will be optimized. Animal toxicity studies and a dose-ranging efficacy and safety study in women will be performed. An efficacious and safe Lactobacillus suppository for colonization of the vagina could lead to maintenance of an intact vaginal ecosystem resulting in decreased prevalence of genital tract infections among women of childbearing age.Proposed Commercial Applications:A commercial suppository capable of re- establishing the optimal vaginal ecosystem could decrease occurrence of genital tract infections. There are 57.4 million women of child-bearing age (15-44 years old) in the U.S. Only half of these women are colonized with H. producing lactobacilli, a primary defense mechanism against genital infections. The commercial need is evidenced by the estimated 10 million office visits for vaginal complaints each year.