ORGAN SPECIFIC IMMUNOSUPRESSION

DESCRIPTION: BREONICS is developing ENDOMATRIX, a natural, matrix membrane, capable of serving as an immunomodifying agent rendering allografts nonimmunogenic and nonthrombogenic on an organ-specific basis. Previous studies indicated that ENDOMATRIX has the potential to inhibit allorecognition by interrupting the interface between donor endothelium and recipient immunocompetent cells. Since our last submission, studies have been completed defining the dose and application method for applying the immunomodifying therapy to canine kidneys. The ENDOMATRIX therapy was administered via a new organ preservation technology called Exsanguinous Metabolic Support (EMS) being developed by BREONICS with our collaborative partner Hospital Products Division Abbott Laboratories. Based upon these results, canine autotransplantation studies have been completed that demonstrate the ability to coat the vascular lumen within an intact organ. These studies demonstrate that ENDOMATRIX therapy did not adversely affect kidney function. We are requesting funding to perform a feasibility study to evaluate the efficacy of ENDOMATRIX therapy in preventing allograft rejection. The proposed study will use a canine allo-transplantation model and compare graft outcomes in two test groups of ENDOMATRIX treated kidneys to control animals given standard immunosuppression. The successful development of ENDOMATR1X therapy could potentially diminish the incidence of chronic graft rejection by preventing allosensitization and eliminate the systemic toxicity associated with traditional immunosuppressive regimens. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE