Healthcare Industry News: diabetic nephropathy
News Release - May 10, 2006
NephroGenex Licenses Pyridorin(TM) for Diabetic Nephropathy and Acute Renal FailureCompany announces plans to pursue diabetic nephropathy 'progressors' and launch clinical trial for acute renal failure
CARY, N.C., May 10 (HSMN NewsFeed) -- NephroGenex, a biotechnology company developing treatments for kidney disease utilizing molecular profiling, announced today the signing of a licensing agreement with BioStratum Incorporated that acquires commercial rights to Pyridorin(TM) (pyridoxamine dihydrochloride) for diabetic nephropathy. Pyridorin(TM) has been evaluated in two Phase II clinical trials demonstrating in both a significant treatment effect in retarding the progression of diabetic nephropathy. The Company also announced the completion of a licensing agreement with Vanderbilt University covering Pyridorin's use as a treatment for acute renal failure.
Developing treatments for diabetic nephropathy is problematic because of significant patient variability in the progression of the disease. As a result, adequate powering of Phase III trials necessitates large patient populations and long treatment periods. This has been a major obstacle in the development of therapies for this debilitating and costly disease.
Recent advances in molecular urinalysis have determined biomarkers that can identify with a high level of accuracy diabetic patients with nephropathy. NephroGenex is expanding on these advances to identify diabetic nephropathy "progressors" for recruitment into Phase III clinical trials. By removing "non-progressors" from the trial, the prospects for demonstrating a significant treatment effect are dramatically improved. This is supported by stratification analysis of Pyridorin(TM)'s Phase II results that indicates by removing patients with less severe disease, a substantial increase in the treatment effect is observed.
Included in the licensing agreement with BioStratum are second-generation compounds including BST 605. This compound exhibits improved potency over Pyridorin(TM), and has successfully completed initial preclinical efficacy and toxicity studies.
NephroGenex has also acquired exclusive commercial rights to advances by Dr. Billy Hudson, Dr. Paul Voziyan, and Dr. Alp Ikizler from Vanderbilt University's School of Medicine that demonstrate Pyridorin(TM) can scavenge "reactive oxygen species" (ROS) and toxic carbonyl compounds. These harmful compounds have been shown in a study by Dr. Ikizler and his colleagues to be dramatically elevated in acute renal failure (ARF) patients, and are suspected of contributing to the high mortality rates seen in this patient population.
"We were surprised to see such a dramatic increase in oxidative stress- induced reaction products in acute renal failure patients, even when compared to end-stage renal disease patients on dialysis," said Dr. Ikizler. "These oxidative reaction products have been thought to play a significant role in the inflammatory response seen in organ failure and other critical-care conditions. Our results highlight their potential pathogenic significance in ARF."
"Approximately 100,000 cases of ARF develop in critically ill patients in the US each year," said Dr. Wesley Fox, President and CEO of NephroGenex. The Company is planning to initiate Phase IIa and IIb clinical trials to evaluate Pyridorin(TM) as a treatment to reduce the severity of acute renal failure, and decrease the mortality rate of acute renal failure patients in the intensive care unit.
About NephroGenex, Inc.
NephroGenex is applying the latest advances in molecular profiling technologies to unravel the complex pathologies found in kidney disease, and overcome longstanding obstacles for drug development in this field. The Company is acquiring commercial rights to clinical-stage candidates that exhibit activity toward established renal pathology, and determining renal molecular profiles and biomarkers that identify patients that are likely to respond to therapy. The resulting molecular-based patient recruitment strategy can dramatically reduce the cost, time and risk of late stage clinical trials, and improve the prospects for achieving significant treatment effects. The Company is also applying renal molecular profiling to identify and validate novel molecular targets for the leading kidney diseases.
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