Research Project
2065542
Cryptosporidiosis currently affects 3-10% of AIDS patients in the U.S., and is considered the leading cause of life threatening diarrhea in these patients. There are no recognized therapeutic measures to combat the disease to date. Hyperimmune bovine anti-Cryptosporidium colostrum has been shown to provide clinical benefit in limited studies. The goal of these specific aims is to perform full-scale product development of Cryptosporidium hyperimmune bovine colostrum IgG concentrate, also known as Bovine Anti- Cryptosporidium lmmunoglobulin (BACI). This material, manufactured by Immucell Corporation, has been prepared in pilot scale and Investigational New Drug application #4122 has been filed with the FDA. The specific aims focus on important studies related to Phase 2-3 clinical studies and a biological product license. These studies include the development of enteric delivery systems incorporating BACI, development of in vitro and in vivo methods for determination of BACI potency, optimum dose, duration and formulation of therapy, vaccination studies designed to optimize the titers in colostrum donor cows, immunization of cows with recombinant candidate protective antigens, and identification of protective epitope(s) recognized by BACI.
