Endotoxin Removal from Plasma for Treatment of Sepsis

With the use of solid phase affinity matrices developed by Clarigen. Inc. endotoxin can be bound and removed from different solutions and biological materials. Recent proposal was prepared to suggest the usefulness of such approach in the treatment of sepsis syndrome. Endotoxin plays a pivotal role in the development of septic shock. The removal of endotoxin from plasma could potentially improve the outcome of such condition. We are suggesting a technology, which has been extensively tested in a different medical application, for purification of dialyzate for artificial kidney therapy. Current Phase I. research will encompass in vitro experiments performed on the small scale in order to demonstrate the safety and efficacy of the suggested technology. Safety, issues related to blood coagulation are addressed. Biocompatibility testing and testing for potential leachables from the suggested compounds has been performed, and reported as preliminary results. Phase I. research will not involve experiments with animals or human subjects. Fresh, pooled human plasma will be purchased from the regional Blood Bank PROPOSED COMMERCIAL APPLICATIONS: The commercial potential of the suggested device by the cost, and lost lives occurring because of sepsis and septic shock. There are approximately 500,00 patients suffering from this condition in one year in the US only. 70,000 of those will loose their life due to the fact that there is no specific treatment for this severe illness. The cost of treatment is about $ 5-10 billion a year. It is impossible to put a value on the lost, often young lives. The US Market for Gram negative sepsis products is about $ 2-3(H) million a year.