NX001, a kidney growth factor peptide that has demonstrated good safety and promising efficacy in two animal models of acute renal failure, is in development for the prevention of delayed graft function (DGF) in kidney transplantation patients, according to NephRx.
In addition, NephRx said that it has been awarded a total of $488,000 in two federal Qualifying Therapeutic Discovery Project (QTDP) grants. One of the grants is to support the clinical development program for NX001, and the other is for NX002, NephRx's derivative of a naturally occurring growth factor in preclinical development as a treatment for oral mucositis, a common, painful and dose-limiting side effect of chemotherapy and radiation therapy in patients with head and neck cancers.
"NX001 has demonstrated promising activity in preclinical models of acute renal failure, and this clinical program is designed to test its effectiveness in helping to prevent or treat delayed graft function in renal transplant patients, a condition that currently lacks effective treatment options," said James Koziarz, PhD, CEO of NephRx Corp. "We also welcome the recently announced federal grants to support the development of both NX001 and NX002."
DGF affects an estimated 20 percent to 25 percent of the approximately 14,000 renal transplants performed annually in the United States, according to the company.
The NX001 Phase I trial is a randomized, double-blind, placebo-controlled, single ascending dose level study of the safety, tolerability and pharmacokinetics of NX001 in healthy volunteers.
"The launch of our first human trial represents an important milestone for NephRx," said F. Gary Toback, MD, PhD, Founding Scientist of NephRx and Professor of Medicine and Cell Physiology at the University of Chicago Medical School. "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. We chose DGF as our initial indication because it represents a well-defined condition where NX001 has the potential to improve near-term kidney function. If these phase I results are positive, phase II trials in DGF patients could get underway by mid-2011."
NX001 has been designated an orphan drug by the U.S. FDA for this indication.
