Diarrhea is the most commonly reported illness in travelers from industrialized nations to the developing world. It is estimated that of the 7.6 million U.S. residents traveling to these regions annually, 30-70% contract Enterotoxigenic E. coli (ETEC) related diarrhea [1-3]. The objective of the studies proposed here is the commercial development of TravelGAMTM, an Anti-ETEC hyperimmune Milk Immunoglobulin, intended for oral prophylaxis against diarrhea caused by ETEC. In Phase I, the clinical importance of including colonization factor antigen I (CFA/I) in the bovine vaccine was determined. During that period, ImmuCell gathered preliminary efficacy data for TravelGAM in a human challenge study. In Phase II the objectives are: (1) Evaluation of improved methods of in vitro CFA expression for use in CFA screening by utilization of cfaD constructs too up-regulate pilus expression in toxin-positive diarrheal ETEC isolates which, in their native state, do not express immuno- detectable CFAs in vitro; (2)Manufacture of TravelGAMTM containing an expanded range of anti-colonization factor antigen (CFA)s) activity suitable for prospective field testing; (3) Scale-up and cGMP manufacture of enteric coated formulation of TravelGAM; (4) evaluation of the efficacy of formulated TravelGAM in a prospective field study in collaboration with the US Navel Medical Research Unit No. 3 in Cairo, Egypt under ImmuCell's Investigational New Drug Application BB-6049. In Phase III, we hope to build upon the prospective study proposed herein by conducting a pivotal effectiveness study in collaboration with a corporate marketing partner.
ImmuCell envisions manufacturing a purified-antibody product based on immune bovine milk whey, for oral administration to patients suffering rom Travelers' diarrhea caused by ETEC. Of the 16 million people who travel from industrialized to developing countries each year 6 million are Americans. Best estimates predict that at least one third, or 2.7 trillion individuals from the U.S. will experience Travelers' diarrhea per year.
