A little old...
Adprotech's APT070 enters Phase IIa trials in kidney transplantation
26 February 2003
Adprotech Limited, the biopharmaceutical company, announced today that its most advanced therapeutic, APT070, has entered Phase IIa clinical trials to evaluate its ability to prevent graft dysfunction in kidney transplantation.
Non-living donor kidney transplants are prone to Ischaemia Reperfusion (I/R) injury, which occurs when the transplanted organ is subjected to oxygen deprivation (ischaemia) during harvesting and storage and damaged by the recipient’s immune system when it is connected to the patient’s blood supply (reperfusion). I/R injury results in failure of graft function (Primary Non Function) or delayed graft function (DGF). Patients suffering from DGF require hospitalization and dialysis for the first weeks post-transplant. They are also at higher risk of rejection and experience reduced long-term graft survival.
APT070 has a unique mode of action. It is designed to reduce I/R injury by binding to kidney 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. APT070 also differs from other transplant drugs because it is perfused through the donor kidney prior to transplantation. This provides protection before grafting, avoids systemic administration and reduces the risk of toxicity.
‘This is excellent news for Adprotech and the 20,000 patients who receive non-living donor kidney transplants each year’ commented Dr Nick Coppard, Adprotech Director of Development. ‘Existing transplant therapies are generally unable to prevent I/R injury and the European Medicines Evaluation Agency has granted APT070 Orphan Drug Status for kidney transplantation in recognition of this fact. Upon approval Adprotech will benefit from 10 years of market exclusivity for APT070 in this indication.’
The randomized, double blind, dose escalating Phase IIa study will evaluate the safety, biodistribution and effect of APT070 on complement attack compared with placebo in 45 transplant patients. The trial will be conducted at several University hospitals in the UK and led by Professor Stephen Sacks at Guy’s Hospital, London, UK.
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. The drug is also in Phase II clinical trials for rheumatoid arthritis.
Adprotech is a biopharmaceutical company which applies its understanding of the immune system and its unique drug modification capabilities to develop products which address serious illnesses including organ transplant rejection, rheumatoid arthritis and bacterial infection. In addition to its promising product portfolio the company has revenue-generating platform technologies including ‘Prodaptin™’ which enables site specific targeting of protein therapeutics.
For more information please contact:
Nicki Brimicombe – NB Public Relations – 44 (0) 1883 732353
Kieran Murphy – Adprotech – 44 (0) 870 444 6144
Background Notes for Editors
Adprotech
• Adprotech was formed in August 1997 when it was spun out of
Smith Kline Beecham. The company is privately owned.
It raised £5.4 million on its foundation when investors included
3i Group, Prelude Technology Investments and Alta Berkeley.
In March 2000 Adprotech secured £5.6 million from existing investors
and MB Venture Capital. The company raised a further £13 million
from existing investors in December 2000.
• Adprotech is working with a number of companies to apply
Prodaptin™ to their drug development programmes.
• The company is based in Chesterford Research Park, Cambridge,
UK.
• For further information on Adprotech please see the website at
www.adprotech.co.uk.
About APT070
• The complement system is central to the body’s immune response. APT070 is based on part of a naturally occurring complement inhibitor protein which, when attached to cells, protects them from complement system attack. Adprotech has isolated the active portion of the natural protein and modified it to optimise its application in this indication
• The kidney binding capabilities of APT070 have been achieved through the application of Adprotech’s molecular targeting mechanism, Prodaptin, which retains therapeutic proteins at the cell or tissue surface. The application of APT070 to renal transplantation has been developed in collaboration with UK university hospitals including Guy’s Hospital in London.
• Prodaptin harnesses a technique used in nature by certain intracellular proteins to target specific cell types and achieve transient membrane attachment. It centers on two or more elements which achieve poor binding to the cell in isolation, but which secure good attachment in combination.
• Prodaptin makes use of a series of synthetic chemical tags which incorporate these ' Addressin' targeting units and which are used to modify the structure of the protein therapeutic. The technique does not create a radically different entity, which means that the mode of action is preserved. However, the tags target the protein more effectively to the 'membrane address' and enable the drug to be retained at the cell or tissue surface.
Prodaptin offers a number of benefits:
a) Lower effective drug dosage should improve side effect profiles, reduce the cost of goods and improve profit margins.
b) Novel modes of delivery are possible with drug retention at sites of delivery
c) Patent life extension through modifying existing drugs.
d) Product differentiation from competitive compounds.
e) Wide applicability - Prodaptin can be applied to create engineered cells, and to target proteins, peptides or new chemical entities... |
