Novel Treatments to Abolish Inflammatory Mediators in Hemodialysis

Period of Performance: 07/01/2009 - 06/30/2011


Phase 1 SBIR

Recipient Firm

Novelmed Therapeutics, Inc.
Cleveland, OH 44106
Principal Investigator


DESCRIPTION (provided by applicant): Approximately 400,000 people with end stage renal disease undergo hemodialysis in the United States each year. During the hemodialysis procedure, the patient's blood circulates through the dialyzer and back to the patient. As a result, the patient's blood encounters the artificial surfaces of the dialyzer and the tubings that connect the patient to the dialyzer. As a result, the complement alternative pathway is activated, causing generation of substantial amounts of C3a and C5a anaphylatoxins. These anaphylatoxins activate neutrophils, monocytes, and platelets, and trigger the inflammatory cascade. NovelMed has developed a monoclonal antibody, which prevents a) C3a, C5a, C5b-9, production, b) neutrophils, monocytes, and platelet activation, and c) TNF-alpha production. In this application, we propose testing the feasibility of using Bikaciomab to prevent the exacerbated inflammatory response that occurs when blood circulates through the dialyzer and associated tubing. Based on current preliminary data, it is clear that Bikaciomab is a novel, target specific, and highly potent drug candidate that would prevent inflammation during dialysis. We believe that such drugs would increase the quality of life for hemodialysis patients. PUBLIC HEALTH RELEVANCE: Approximately 350,000 people with end stage renal disease undergo hemodialysis in the United States each year. In this already compromised patient population, virtually every patient suffers side effects from this hemodialysis procedure at one time or another due to activation of the alternate complement pathway (AP). Bikaciomab blocks the alternative pathway in blood circulating through an extra corporeal blood circulation model of hemodialysis. It is hoped that such an approach will eventually result in improved morbidity and mortality in the patients suffering from End Stage Kidney Failure. Public Health Relevance Statement Page 7