Orphan status for ProtAffin's PA401

Austria's ProtAffin AG, a biotechnology company developing anti-inflammatory therapeutics that act by targeting cell-surface glycan structures, has received Orphan Drug designation from the US Food and Drug Administration for its lead product PA401 (also designated as recombinant human CXCL8 mutant). The agent has also been granted orphan status in the European Union. The US designation is for the "prevention of delayed graft function after solid organ transplantation." PA401 is ProtAffin's lead anti-inflammatory product and is a modified form of the human chemokine IL-8, which acts as a potent, targeted anti-inflammatory protein preventing the infiltration of neutrophils that is often seen in the first days following solid organ transplantation.

Jason Slingsby, chief executive of ProtAffin, said: "there remains a real unmet medical need for an innovative anti-inflammatory product that works to prevent the delay in graft function that is so often experienced following solid organ transplants. There are no products currently authorized in the USA to prevent this condition and we hope to make an important contribution to the field of clinical medicine and to improve patient outcomes in transplantation and other inflammatory diseases."