Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The recombinant human C1 inhibitor (rhC1INH) may play an important therapeutic role in the prevention of delayed graft function (DGF) after solid organ transplantation, according to the publication of preclinical evidence by Pharming Group.
Subscribe to our email newsletter
The published study results further indicated the potential for the product in the treatment of ischemia- reperfusion injuries and in particular in the prevention of DGF following kidney transplantation.
Pharming claimed that its rhC1INH reduced several ischemia/reperfusion- related inflammatory processes and limited tissue damage in a swine model of ischemia/reperfusion-induced renal damage. As the inflammatory processes in pigs are very similar to those in humans, these results form a clear indication of the potential of rhC1INH for treatment and prevention of ischemia tissue damage in patients.
In October 2009, Pharming announced the beneficial results of another preclinical study in the field of ischemia-reperfusion injuries, focussing on the reduction of damage following brain infarcts (stroke). Several studies in rodents indicate that the complement system plays a pivotal role in renal ischemia reperfusion injury. To date, however, limited information was available from humans and larger animals. This swine study has been supported by a research grant from Pharming and was performed by researchers from the University of Bari, Italy.
Dr Castellano, said: “DGF is an important medical problem. In the EU, each year approximately 35,000 organs are transplanted. These procedures are costly and patients often have to wait a long time before transplantation can be performed. Further improvement of short-term and long-term outcomes will, therefore, provide a valuable medical and economical benefit. The results of our recent study are very promising in this regard.”
Pharming’s rhC1INH has orphan medicinal product designation from the European Medicines Agency for prevention of DGF after solid organ transplantation. The status is granted to a product for which it is made plausible that it will have a positive therapeutic effect on a disease or condition which is relatively rare in the EU and provides incentives for research, development and marketing, in particular by granting exclusive marketing rights for a ten-year period.