The Neo-Kidney Augment, for which Tengion is conducting Phase 1 trials in Sweden and the U.S., 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 United States Renal Data System (USRDS), there are approximately 26 million adults in the U.S. who have CKD and 100,000 new patients who start on dialysis each year. 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, $39 billion in direct U.S. 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 completed enrollment of five patients in the Phase 1 clinical trial in Sweden during the second quarter of 2013 to evaluate safety and delivery of the Neo-Kidney Augment product in patients with CKD. The Neo-Kidney Augment is safe and well tolerated in the five patients implanted to date. In March 2014, the Company received regulatory approval from the Medical Products Agency (MPA) to expand enrollment in this trial to a total of 15 patients. This Phase 1 clinical trial will evaluate the safety and implantation of the Neo-Kidney Augment and involve delivery of an active regenerative dose of Neo-Kidney Augment in patients with CKD who will be followed for up to two years.
The Company also initiated of a Phase 1 clinical trial in the U.S. under an open Investigational New Drug (IND) application for the Neo-Kidney Augment in 2014. The U.S. Phase 1 clinical trial will evaluate the safety and delivery of the Company’s Neo-Kidney Augment in patients with CKD. It is expected to enroll up to 12 patients and will follow each patient for up to two years. The Company anticipates that it will complete patient enrollment during 2014.