Kalamazoo-based NephRx Corp. announced Thursday that a new study has shown that its novel peptide NX002 demonstrated significant efficacy when tested in an animal model of oral mucositis.
Mucositis is a debilitating inflammation of the mouth and gastrointestinal tract, a debilitating side effect of many forms of cancer therapy that limits the dose a patient can receive. It affects more than 400,000 patients who receive chemotherapy or radiation treatment in the U.S. each year. Current treatment options are very limited.
The pain resulting from mucositis can be so severe that it is cited by patients as a major reason for discontinuing cancer treatment. In severe cases, mucositis prevents eating and often results in hospitalization. Mucositis afflicts approximately 15 to 40 percent of patients receiving standard-dose chemotherapy and 76 to 100 percent of patients receiving chemotherapy for bone marrow transplant. It affects virtually all patients receiving radiation therapy for head, neck and gastrointestinal cancers.
“The efficacy demonstrated by NX002 in our studies is especially meaningful given the predictive value of the animal model used,” said Dr. Stephen Sonis, Chief Medical Officer of Biomodels LLC, the preclinical organization that conducted the trial. “The mechanisms by which NX002 is likely exerting its effect are novel and represent a new approach to the development of a treatment for this onerous condition.”
NX002 is a peptide derived from the naturally occurring growth factor AMP-18, which has been shown to stimulate the growth of epithelial cells and to promote wound healing after injury. Its multiple biological properties include the ability to protect cells from injury, stimulate cell growth and migration, and increase the accumulation of proteins that bind cells together. In the new mucositis study, animals treated with NX002 had reduced levels of oral ulceration and a more rapid recovery, with no evidence of toxicity.
“We are delighted with the promising efficacy demonstrated by NX002 in this well-designed study,” said F. Gary Toback, M.D., founding scientist of NephRx and professor of medicine and cell physiology at the University of Chicago Medical School. “Mucositis is a painful and debilitating side effect of cancer therapy that can be dose-limiting, jeopardizing the chances for successful treatment. Based on these positive data, we can now start the detailed toxicity studies needed to support clinical testing of NX002 as a potential new treatment for oral mucositis.”
NX002 may also have applications in acute and chronic diseases of the gastrointestinal tract, such as Crohn’s disease and ulcerative colitis.
In a separate development, NephRx reported that it has filed an investigational new drug application with the U.S. Food and Drug Administration for a Phase I trial of NX001 for the prevention of delayed graft function in renal transplant recipients. NX001 is a kidney growth factor peptide that has demonstrated good safety and promising efficacy in two animal models of acute renal failure. The trial is expected to begin enrolling patients shortly.
More at www.nephrx.com.
(c) 2010, WWJ Newsradio 95o. All rights reserved.