Research Project
6517563
End stage renal disease (ESRD) is a devastating disease with a very high cost of treatment, especially for poor patients worldwide. Our R&D goal is to progressively develop a low-cost, non-invasive gut-based treatment for efficient removal of uremic solutes in renal failure patients. We plan to develop a therapeutic oral formulation in a stepwise methodology beginning with generation I to its ultimate optimized product generation IV. This is based on a formulation of a mixture of modified sorbents plus a genetically engineered bacterium which, in the gut, would adsorb and eliminate various uremic solutes through the bowel route. Our phase I proposal is specifically directed to develop the generation I formulation consisting of zeolite based sorbent material will be replaced by a genetically engineered E. coli DH5 cells which is expected to demonstrate better urea removal capabilities. These Generation I and Generation II formulations will be investigated for their in vitro adsorption capabilities for urea, creatinine and uric acid removal. These phase I R&D investigations are expected to furnish data necessary to accelerate the development of the generation III and subsequently the optimized generation IV formulation for our phase II studies. PROPOSED COMMERCIAL APPLICATION: The fully developed product will have immense applications towards treatment of uremic patients from predialysis to ESRD and possibly substitute the need for dialysis, especially in developing and under- developed countries. It is equally feasible that our oral formulation may also have applications as a adjunct therapy for dialysis.
