The Neo-Kidney Augment, for which Tengion is conducting a Phase 1 trial in Sweden, is being developed with the goal of using a patient's own cells to augment or replace renal function for patients with chronic kidney disease (CKD) who are rapidly progressing toward end stage renal disease (ESRD).
According to the 2011 Annual Report of the United States Renal Data System (USRDS), there are over 40 million people in the United States with CKD. Patients with ESRD have CKD that has progressed to a point of little to no kidney function and require dialysis or a kidney transplant to survive. Dialysis extends the lives of patients with ESRD but has many limitations, including infections, hernias and the need to undergo the procedure up to three times per week. In addition, bone loss and anemia are common complications of advanced CKD, mainly due to an inability of the kidneys to produce enough Vitamin D and erythropoietin, a hormone that controls red blood cell production. ESRD is associated with an approximate 20% mortality rate per year and, according to the USRDS, $29 billion in Medicare costs each year are attributable just to ESRD patients.
Kidney transplantation remains the most desirable and cost-effective form of kidney replacement therapy; however, there is a chronic shortage of donor organs. It is expected that the Neo-Kidney Augment will delay or prevent progression to ESRD, representing an opportunity to improve patient health and quality of life, defer or eliminate the costs associated with dialysis, and grant additional time in which a patient can secure a donor kidney.
Tengion's scientific publications have reported data regarding the regenerative capabilities of the Neo-Kidney Augment in preclinical models, and improvement in functional renal mass, improvements in kidney filtration, urine concentration, electrolyte balance, blood pressure and survival.
Tengion initiated the Phase 1 clinical trial during the second quarter of 2013 to evaluate safety and delivery of the Neo-Kidney Augment product in up to five patients with CKD in Sweden. The Company plans to enroll up to five patients in the Phase 1 trial in 2013 and will follow each patient for up to two years.