Quark Pharmaceuticals, Inc., the world leader in clinical development of RNAi-based therapeutics, announced today the presentation of a poster at the 2010 American Transplant Congress titled, "A Nomogram for Predicting Risk of Delayed Graft Function Following Machine Perfusion of Renal Transplants." The poster presents a new model developed by William Irish, Ph.D. of CTI Clinical Trials and Consulting Services in cooperation with Quark and using recent data from the United Network for Organ Sharing/Organ Procurement and Transplantation Network (UNOS/OPTN) database to predict the risk of delayed graft function (DGF). DGF occurs when kidney recipients require dialysis during the first week following transplantation.
As part of the ATC poster session focused on issues relevant to deceased donor kidney transplantation, Dr. Irish will present the new risk model for predicting the likelihood of DGF in recipients of donor kidneys exposed to machine perfusion. This model showed good agreement with the observed proportion of DGF in a validation data set and was valid across different donor subgroups. This model could potentially help predict the likelihood of DGF. DGF is a significant problem for 24% of all recipients of deceased donor kidneys and 33% of patients who receive kidneys from Extended Criteria Donors (ECDs). ECDs are older donors or donors who may have health issues that, in the past, would have precluded their acceptance. These donors are now accepted, as the number of people waiting for a kidney transplant in the USA has grown progressively and is far in excess of the number of available donor kidneys.
Daniel C. Brennan, MD, professor of medicine, medical director of Renal Transplantation Service, Washington University, St Louis said, "This nomogram builds on prior models and is now applicable to kidneys that have been machine perfused, a growing segment of deceased donor kidneys, especially ECD kidneys which are at increased risk for DGF. With this index in hand, physicians caring for potential transplant patients may better anticipate and assess individual risks during the early post transplant period."
Daniel Zurr, Ph.D., President and Chief Executive Officer of Quark Pharmaceuticals, said, "We are pleased to share this research with the American Transplant Congress, and to further contribute to the study and treatment of Delayed Graft Function. At this conference, Quark also will present results of a Phase I study evaluating QPI-1002 in 40 transplant recipients of kidneys from deceased donors, including ECD. The data safety monitoring board for the study determined there were no dose-limiting toxicities in any dose cohort and that the results support continued evaluation of QPI-1002 for prophylaxis of DGF in deceased donor transplantation. While QPI-1002 has significance for us and the RNAi industry as the first systemically-delivered siRNA to be tested in human trials, it is also important to the renal transplant community as a completely novel investigational approach to addressing DGF."
Quark Pharmaceuticals, Inc.