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NephRx Corp. Awarded U.S. Patent for NX002 for Treatment of Oral Mucositis


Wednesday, November 30, 2011

Kalamazoo, MI -- NephRx Corporation today announced issuance of a new U.S. patent for its novel peptide NX002, which currently is in preclinical development for the treatment of oral mucositis and other diseases of the gastrointestinal tract. This new patent follows an NX002 patent for inflammatory bowel disease issued earlier this year. Previously, NephRx reported that NX002 had demonstrated significant efficacy when tested in well-validated animal models of oral mucositis. Mucositis is a debilitating and often dose-limiting condition that affects more than 400,000 cancer patients who receive chemotherapy or radiation therapy in the U.S. each year. Current treatment is predominantly palliative with a goal of providing symptomatic relief.

"This new patent for oral mucositis further confirms the potential utility of NX002 as a treatment for a number of serious disorders of the gastrointestinal system," said James Koziarz, President and CEO of NephRx. "Oral mucositis is a painful and debilitating side effect of cancer therapy that can be dose-limiting, jeopardizing patients' chances for successful treatment. We are now preparing to conduct the detailed toxicity studies needed for the NX002 clinical program, and we are also working to broaden further the intellectual property around this promising compound."

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 using 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.

NX002 also has potential therapeutic utility in other 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.

The U.S. Patent and Trademark office has issued Patent No. 8,017,576, "Methods and Compositions to Treat Mucositis." Rights to this patent, which protects NX002 and related compounds, have been exclusively licensed to NephRx by the University of Chicago, where the drug was discovered in the laboratory of Dr. F. Gary Toback.

About Oral Mucositis

Mucositis is an inflammation and ulceration of the lining of the mouth, throat or gastrointestinal tract that occurs in cancer patients who receive radiation and/or chemotherapy. 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% of patients receiving standard-dose chemotherapy and 76-100% 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.

About NephRx

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. NX001 is currently in Phase I testing and will be developed initially for the treatment of delayed graft function in kidney transplant patients. NX002 is in preclinical development as a treatment for oral mucositis, a common, painful and dose-limiting side effect of cancer chemotherapy and radiation therapy. For more information, visit www.nephrx.com.



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