Pharming Group Wins FDA Approval for Kidney Transplantation Study
Posted on: Friday, 5 September 2008, 09:00 CDT
Biotech company Pharming Group has announced that the FDA has authorized a clinical study with recombinant human C1 inhibitor for the treatment of antibody-mediated rejection in kidney transplantation.
Hans Sollinger of the University of Wisconsin, Madison will conduct the clinical trial with recombinant human C1 inhibitor (rhC1INH) under an investigator IND from the FDA.
Recombinant human C1 inhibitor is a key inhibitor of the classical complement system. In the planned study, rhC1INH will be evaluated in patients with antibody-mediated rejection (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.
Bruno Giannetti, COO of Pharming, said: "We are excited about the opportunity to work together with Dr Sollinger, a pre-eminent transplant researcher and surgeon who led the clinical development of CellCept, a therapy that has greatly benefited transplant patients. We look forward to seeing how rhC1INH may help in transplantation as well as other complement-mediated diseases."
Source: Datamonitor
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