The US Food and Drug Administration (FDA) has authorized a clinical study with recombinant human C1 inhibitor (rhC1INH) for treating antibody-mediated rejection (AMR) in kidney transplantation, as per Biotech company Pharming Group NV.

A clinical trial with rhC1INH under an Investigator IND from the FDA is expected to be conducted by Dr. Hans Sollinger of the University of Wisconsin, Madison.

It is important to note here that more than 15,000 kidney transplants happen in the United States on an annual basis and the organ transplant program at University of Wisconsin was ranked first in the USA in 2005 and 2006 for numbers of kidney transplants performed.

From News-Medical.Net:

Recombinant human C1 inhibitor is a key inhibitor of the classical complement system. In the planned study, rhC1INH will be evaluated in patients with AMR for its ability to prevent the inflammatory damage seen in the kidney, improve organ function, and reduce the likelihood of graft loss. In this study, Dr. Sollinger will study patients with AMR to compare rhC1INH against standard of care, which consists of a combination of non-specific treatments including plasmapheresis, steroids and intravenous immunoglobulin. Previously, Pharming successfully completed a Phase I safety study with rhC1INH in healthy volunteers.

Dr. Hans Sollinger, University of Wisconsin commented: “I am enthusiastic about taking rhC1INH forward in this clinical trial for antibody-mediated rejection. Antibody-mediated rejection is a serious and costly complication for which there is no specific therapy. RhC1INH has great potential in changing the way we treat AMR and extend the life of a transplanted kidney.”

Dr. Bruno Giannetti, COO of Pharming remarked that he is excited to see how rhC1INH may help in transplantation as well as other complement-mediated diseases.

Tags: kidney transplantation, plasmapheresis, steroids

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