Nephrx News Feed

NephRx Corp. Awarded U.S. PATENT for nx002 for treatment of oral mucositis

NephRx — Wed, 30 Nov 2011 17:17:00 +0000

Kalamazoo, Michigan - November 30, 2011 - 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.

NEPHRX CORP. AWARDED U.S. PATENT FOR USE OF NOVEL GROWTH FACTOR PEPTIDE NX002 IN INFLAMMATORY BOWEL DISEASE

NephRx — Thu, 24 Mar 2011 11:14:00 +0000

Kalamazoo, MI – March 23, 2011 – NephRx Corporation today announced issuance of a new U.S. patent for use of its novel growth factor peptide NX002 as a potential treatment for inflammatory bowel disease (IBD). Animal studies suggest that NX002 may have applications in acute and chronic diseases of the gastrointestinal tract, including 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.

NX002 is currently in preclinical studies for the treatment of IBD and in late preclinical development as a potential treatment for oral mucositis. “Issuance of this new patent is important given the promising utility of NX002 as a potential treatment for serious disorders of the gastrointestinal system,” said James Koziarz, President and CEO of NephRx.

“We have been encouraged by the efficacy demonstrated by NX002 in models of oral mucositis, and early studies suggest its distinctive mechanism of action also has potential as a novel treatment for inflammatory bowel disease. This family of painful and disabling conditions affects more than a million patients in the U.S. alone, and despite recent advances, many remain poorly treated.”

NX002 is a peptide derived from the naturally occurring growth factor AMP-18. 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.

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.

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) refers to a group of inflammatory conditions of the colon and small intestine, including ulcerative colitis and Crohn's disease, which cause chronic inflammation of the intestinal tract and lead to a variety of symptoms, including ulceration, pain, vomiting, diarrhea, edema, bleeding and fluid loss. IBD is a chronic condition with periods of active disease alternating with periods of remission. It can limit quality of life and may lead to life-threatening complications. IBD is thought to result from an immune reaction of the body against its own intestinal tissue. It is treated with surgery and with a variety of systemic and local anti-inflammatory and immunomodulatory agents, but many involve potentially serious side effects and efficacy varies. According to the American College of Gastroenterology, there are more than one million people with IBD in the U.S. alone. These diseases account for 700,000 physician visits per year and 100,000 annual hospitalizations.

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 late stage preclinical development as a potential treatment for oral mucositis and in preclinical studies for the treatment of inflammatory bowel disease.

For more information, visit www.nephrx.com.

NephRx Corp. initiates phase I trial of its leading drug...

NephRx — Thu, 18 Nov 2010 13:12:00 +0000

November 11, 2010

NephRx Corp. initiates phase I trial of its lead drug being developed for prevention of delayed graftfunction in kidney transplant patients

--Company Receives Federal QTDP Grants Totaling $488,000 for Development of NX001 and Oral Mucositis Agent NX002--

NephRx Corporation today announced that it has initiated a Phase I clinical trial of its lead compound NX001 and has successfully dosed the first subject in the study. 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.

Separately, NephRx announced 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, Ph.D., 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 20-25% of the approximately 14,000 renal transplants performed annually in the U.S. Patients are put on dialysis to "rest" the transplanted kidney in the hope that this will correct metabolic imbalances and allow kidney function to return spontaneously. Studies have shown that DGF can negatively affect future graft function and can increase the incidence of acute rejection episodes. Kidney grafts with impaired function require the most intense follow-up and therapeutic management and are accordingly the most costly.

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, M.D., Ph.D., 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.

NX002 has been shown to stimulate the growth of epithelial cells and to promote mucosal wound healing after injury. In a recent 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 intends to initiate preclinical toxicology studies of NX002 in the coming months, with clinical trials targeted for late 2011.

The Qualifying Therapeutic Discovery Project, enacted as part of the federal Patient Protection and Affordable Care Act of 2010, is designed to provide grants or tax credits to qualified biotechnology company projects that demonstrate the potential to result in new therapies to treat areas of unmet medical need; to prevent, detect, or treat chronic or acute diseases or conditions; to reduce long-term health care costs in the United States; or to significantly advance the goal of curing cancer within 30 years.

NephRx Corp. reports nx002 is effective in preclinical model of oral mucositis

NephRx — Thu, 21 Oct 2010 14:23:00 +0000

October 7, 2010

Sets Stage for Toxicology Studies Preparatory to Human Clinical Trials of This Novel Growth Factor Peptide

NephRx Corporation today announced 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 and often dose-limiting side effect of many forms of cancer therapy that 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 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., Ph.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 (IND) 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.

About Oral Mucositis

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% 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 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. Lead product NX001 is a kidney growth factor peptide for acute renal failure that is currently in preclinical development for treatment of delayed graft function in transplant patients. NX002, a derivative of a naturally occurring growth factor, is 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 and other cancers. For more information, visit www.nephrx.com.

NephRx makes strategic management changes

NephRx — Mon, 20 Sep 2010 21:20:00 +0000

NephRx makes strategic management changes to better position the Company at this critical time in the development/commercialization process

James J. Koziarz named NephRx CEO.

During the June, 2010 board meeting, Dr. James Koziarz was elected President and CEO of NephRx Corporation. Dr. Koziarz has been a board member since 2007 and brings outstanding experience and leadership to his expanded corporate role.
Dr. Koziarz has been involved in the diagnostics business for over 25 years, beginning as a bench chemist at Abbott Laboratories in 1979. In this capacity, he helped developed Abbott’s first ELISA test for CEA, later moving into product support for the newly formed Cancer Business Unit in 1980. His next position was that of R&D manager for endocrine function diagnostics. He was promoted to general manager of that business unit and later named the general manager of Abbott’s Hepatitis and Retrovirus business unit, in which he managed the development of numerous assays for HIV and was involved with regulatory bodies internationally. Dr. Koziarz was appointed Vice President for Research and Development for the Abbott Diagnostics Division in 1992 and was elected corporate officer in 1993. Since his retirement from Abbott in 2004, he has focused his efforts on assisting start-up companies. Dr. Koziarz received his B.S. degree in chemistry from DePaul University and a doctorate in biochemistry from the University of Chicago.

In July of this year, Dr. Ann Berger, Vice-president of Research and Development, chose to re-retire, but will continue with the Company on a consulting basis. For over five years Dr. Berger guided all aspects of research and development on both NX001 and NX002, and we are pleased Ann has agreed to remain involved in the months ahead.

As a result of Ann’s reduced schedule and the Company entering into clinical trials, two new positions were added in July of 2009. Dr. Robert C. Marshall was named Vice-president, Clinical Development, and Dr. James T. VanderLugt became Chief Medical Officer. A brief background on these three individuals is provided below.

Robert C. Marshall, Ph.D., Vice President, Clinical Development
Dr. Marshall has over 35 years experience in pharmaceutical R&D, joining the U.K. subsidiary of Upjohn in 1972 as a research pharmacologist. Rising through the research scientist levels, he moved into management in 1982, supervising the construction, set up and management of a bioanalytical capability within the U.K. laboratories. In 1987, Dr. Marshall transferred to Kalamazoo, Michigan, as a Senior Project Manager, remaining through the mergers of Upjohn with Pharmacia, Searle/Monsanto and finally Pfizer. He successfully managed project teams to obtain approvals for 6 products (in US and/or ex-US) – Mirapex and Cabaser (Parkinson’s disease), Caverject and Caverject Impulse (erectile dysfunction), Xanax XR (anxiety & panic disorder) and Edronax/Vestra (depression). In 2003, Dr. Marshall became the clinical Development Operations Team Lead for the Phase I/IIa studies managed by Pfizer’s Ann Arbor site. Dr. Marshall received his B.Sc. and Ph.D. (in pharmacology) from the University of London in the U.K., completing his doctorate research at King’s College Hospital Medical School.

James T. VanderLugt, Chief Medical Officer
Dr. VanderLugt has over 28 years of experience in the pharmaceutical industry conducting clinical research in Phases I through IV. He began his career at The Upjohn Company’s Clinical Research Unit in 1981. While at The Upjohn Company he directed the first Phase II study of piogliazone. Beginning in 1989, he led the development of the antiarrhythmic drug, Corvert, and designed and conducted the Phase I, II and III studies which culminated in the filing of an NDA in October 1994. He has been involved in drug development in multiple therapeutic areas including cardiovascular, metabolic, thrombosis, inflammation, dermatology, CNS, GI, and ophthalmology. In 1996 following the merger of Upjohn and Pharmacia, he became Director of Ophthalmology and Cardiovascular Medicine. In 2000 he was appointed Senior Director of Global Medical Services. In 2001 Dr. VanderLugt integrated Global Medical Services and the Medical and Drug Information Unit at Pharmacia and continued as Executive Director of this group following the merger with Pfizer Inc in 2003. He has a BA in Biology from Calvin Collage and a M.D. from the University of Michigan. He completed a residency in Internal Medicine and a fellowship in Clinical Pharmacology at Michigan State University. He is currently Medical Director of Jasper Clinic, Inc. in Kalamazoo Michigan and serves on the Institutional Review Board of the West Michigan Cancer Center. He is on the Medical Staff of Bronson Methodist Hospital in Kalamazoo, Michigan and maintains medical licensure in the State of Michigan.