Background: Over 85,000 solid organs transplantation operations are performed around the world. Of all solid organ transplants, kidney transplants are the most common: in the US there are over 16,000 kidney transplants done every year. The number of transplants per year is determined by the availability of organs. Every year, a large number of people on waiting lists for organs die as a result of the inability of the transplant center to obtain a viable organ. Because viable organs are precious and every instance, have a material effect on a human life, the logistics involved in the care and handling of procured organs, from the source to successful transplantation, are complicated.

Problem: Cold Storage solutions have improved the outcome of kidney transplantation, but ischemic/reperfusion injury still leads to delayed graft function in >20% of patients, which in turn impacts chronic allograft nephropathy (CAN), the major cause of late allograft loss in renal transplant recipients. CAN, a form of vasculopathy, is an accelerated arterial disease that limits the success of transplantation. Increasing L-arginine in stored organs has the potential to limit ischemic damage, thereby allowing for an increase in length of time organs can be stored prior to implantation. Perfusion of organs prior to transplantation presents an ideal opportunity to reduce allograft injury while minimizing potential toxicity to the recipient.

Lumen Therapeutics' Solution: Oligo- L-arginine delivered ex vivo in a rat heart transplant model has been shown to translocate across cytoplasmic membranes, enhance vascular NO production, and decrease neointimal hyperplasia, demonstrating potential for preventing vasculopathy after heart transplantation. This also has implications for other solid organs that are commonly transplanted, including kidney, pancreas, and liver. Lumen is performing additional preclinical studies with LT-1964 (a Cold Storage Solution containing one of Lumen's oligo-L-arginine drugs) in animal models of kidney transplantation that will quantify the short and long term benefits of LT-1964 versus traditional products. Pending completion of these studies, the company will perform clinical studies of LT-1964 in patients receiving kidney transplants.

Potential Benefits:

1. Increased storage time for kidneys, increasing the likelihood of utilization
2. Limiting the degree of ischemic damage in kidneys will help prevent Delayed Graft Function, with a corresponding decrease in the requirement for post-transplant dialysis
3. Decrease in chronic allograft nephropathy