Emerging drug resistance among bacteria is a serious medical problem and has propelled the need for new antimicrobial agents. BisBAL is a novel antimicrobial formulation, where the chelating agent BAl (british anti-lewsite) enhances the inhibitory action of Bismuth by 300-1000 fold against a broad spectrum of bacteria. It is water soluble, stable at high acidic pH, and exhibits extremely high in vitro effects compared to other bismuth preparations (bismuth subsalycilate/subcitrate) available currently. BisBAL may have potential use in multiple conditions, including skin infections, as a coating material on indwelling catheters for prevention of viofilm formation, as an antifoul agent etc. However, our focus in this proposal is to test the efficacy of BisBAL against two important gastrointestinal infections where local effect of antibiotic is highly desirable. To expedite the process, studies planned in this Phase I submission will utilize the collaboration of university professors and the established animal model systems in their laboratories. Peptic ulcer disease (and possible development of gastric carcinoma) is now conclusively proven to result from Helicobacter pylori infection and eradication of the organism is recommended in all symptomatic cases. Presently, several drug regimens are available, each employing multiple medications. These therapies are highly expensive and patient compliance is low due to require of 3-4 doses per day. Virio cholerae causes the classical diarrheal disease, cholera, and is a major problem health in developing countries including Mexico, Central and South America. There are many reported cases of V. cholerae gastroenteritis in the U.S.e very year, and the recent epidemics are around the world have created serious concerns around the U.S.-Mexico border. We will investigate the in vivo antimicrobial effect of BisBAL against these two organisms, where antibiotic absorption of the components of this formulation into blood stream and any subsequent toxicity. Data obtained from these studies will foster the progression to human studies, that can bring BisBAL to the marketplace.
