Therapy to reduce organ transplant failure gets test in humans

Kalamazoo-based NephRx Corp. has begun a test in human patients, a Phase I clinical trial, of its lead compound NX001 and has successfully dosed the first subject in the study.

NX001 is a kidney growth factor peptide that has performed well in two animal models of acute renal failure. NX001 is in development for the prevention of delayed graft function in kidney transplantation patients. A peptide is a molecule formed by joining two or more amino acids. When the number of amino acids is less than about 50 these molecules are named peptides while larger sequences are referred to as proteins.

Delayed graft function affects an estimated 20 percent to 25 percent of the approximately 14,000 renal transplants performed annually in the United States. Studies have shown that delayed graft function negatively affects future graft function and can increase the incidence of organ rejection. Kidney grafts with impaired function require the most intense follow-up and therapeutic management, which makes them the most costly.

The NX001 Phase I trial is a randomized, double-blind, placebo-controlled, single ascending dose level study of the safety of NX001 and what the body does with it in healthy volunteers.

The human trial is an important milestone for the company, says F. Gary Toback, M.D., Ph.D., Founding Scientist of NephRx.  

"Because the kidney is one of the few human organs with the potential for self-repair, our kidney growth factor peptide has the potential to stimulate improved renal function in a number of disorders," says Toback.

If Phase I results are positive the company could initiate Phase II trials by mid-2011.

NephRx Corporation is a clinical-stage biotechnology company dedicated to the discovery and development of therapeutic products for the treatment of acute kidney failure and other renal disorders, and diseases of the gastrointestinal tract, including mucositis, Crohn's disease and ulcerative colitis.  

Writer: Kathy Jennings
Source: F. Gary Toback, NephRx