Organ Transplant Boost For Adprotech Wins US Approval

The US Food and Drug Administration has granted biopharma company Adprotech orphan drug status for APT070 in the prevention of delayed graft function in solid organ transplant.

CEO Kieran Murphy says approval will afford Adprotech seven years market exclusivity, a waiver of the user fee, help in developing clinical trial protocols and entitles the East of England company to tax credits, including up to 50 per cent of certain clinical testing expenses.

Around 14,000 kidney transplant operations take place in the US each year, and up to 58 per cent use organs from non-living donors. Organ survival rates for the latter operations are around 88 per cent at year one but fall to 63 per cent at year five.

Ischaemia reperfusion (I/R) injury and its knock-on effects are associated with many of these failures.

I/R injury occurs when the transplanted organ is damaged by the recipient's immune system when it is connected to their blood supply following oxygen deprivation (ischa-emia) during harvesting and storage.

Injury occurs at a much higher rate in non-living donor transplants and is associated with delayed graft function, higher risk of acute rejection and reduced graft survival time.

APT070 is designed to reduce I/R injury by binding to transplanted tissue and protecting it from attack by a component of the recipient's immune response known as the complement system, following re-initiation of blood flow after grafting.

It also differs from other transplant drugs because it is perfused through the donor organ prior to transplantation.

This provides protection before grafting, avoids systemic administration and reduces the risk of unwanted side-effects.

APT070 is derived from a human protein and its ability to bind to the kidney is mediated by Adprotech's Prodaptin, cell membrane binding technology.

APT070 recently entered Phase IIa clinical trials in the UK to evaluate its safety, biodistribution and effect on complement attack compared with placebo in 45 transplant patients. It is also in Phase II clinical trials for rheumatoid arthritis.

Adprotech is based at Chesterford Research Park near Saffron Walden in the UK.

Copyright © 2003 Business Weekly.

This article posted July 6, 2003.