KALAMAZOO – NephRx Corporation Tuesday announced it was issued a U.S. patent for its peptide NX002 currently in preclinical development for the treatment of oral mucositis – a debilitating and often dose-limiting condition that affects more than 400,000 cancer patients who receive chemotherapy or radiation therapy in the United States each year. Current treatment options are limited.
Previously, NephRx reported that NX002 had demonstrated significant efficacy when tested in well-validated animal models of oral mucositis.
?Issuance of this most recent patent further confirms the promising utility of NX002 as a potential treatment for oral mucositis,? said James Koziarz, President and CEO of NephRx. ?Mucositis is a painful and debilitating side effect of cancer therapy that can be dose-limiting, jeopardizing patients? chances for successful treatment. We look forward to advancing the detailed NX002 toxicity studies needed to initiate the mucositis clinical program for NX002.?
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 mucosal 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 a study in a well-validated mucositis model, animals treated with NX002 had reduced levels of oral ulceration and a more rapid recovery, with no evidence of toxicity. NephRx has begun the preclinical toxicology studies of NX002 needed to initiate mucositis clinical trials targeted for late 2011 or early 2012.
The U.S. Patent and Trademark office issued Patent No. 7910543, ?Control of growth and repair of gastro-intestinal tissues by gastrokines and inhibitors.? Rights to this patent, which protects NX002 and related compounds, have been exclusively licensed to NephRx by the University of Chicago.
NX002 may also have applications in acute and chronic diseases of the gastrointestinal tract, such as Crohn?s disease and ulcerative colitis. It has been shown to stimulate the growth of epithelial cells and to promote mucosal wound healing after injury.
Mucositis is an inflammation and ulceration of the lining of the mouth, throat or gastrointestinal tract associated with cancer chemotherapy and radiation therapy. 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 15-40 percent of patients receiving standard-dose chemotherapy and 76-100 percent of patients receiving chemotherapy for bone marrow transplant. It affects virtually all patients receiving radiation therapy for head and neck and gastrointestinal cancers. In total, an estimated 400,000 patients are affected by mucositis each year in the U.S. alone, and the incidence is rising as use of radiation and chemotherapy increases.
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