Navigation Links
NephRx Corp. Receives Orphan Drug Designation for NX001 for Prevention of Delayed Kidney Graft Function

KALAMAZOO, Mich., Aug. 18 /PRNewswire/ -- NephRx Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product NX001 for the prevention of delayed graft function (DGF) 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.  

"Delayed graft function is a common condition affecting many kidney transplant patients, but current treatment options are limited," said James Koziarz, Ph.D., CEO of NephRx Corp.  "NX001 has demonstrated promising activity in improving kidney function in preclinical models of acute renal failure, and we look forward to initiation later this year of our clinical program to test its effectiveness in helping patients achieve better kidney function post-transplant."

DGF affects an estimated 20-25% of the approximately 14,000 renal transplants performed annually in the U.S.  Currently, there is no treatment for DGF.  DGF patients are put on dialysis to "rest" the transplanted kidney, correct metabolic imbalances and wait for 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 economically most costly.  

"NX001 is an entirely new approach to treating acute kidney dysfunction," noted 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.  "The kidney is one of the few human organs with the potential for self-repair, and we believe a kidney growth factor peptide such as NX001 has the potential to stimulate improved renal functioning in a number of renal disorders.  DGF represents a well-defined condition where we hope to show that NX001 can improve near-term kidney function in Phase II trials planned for mid-2011."

Orphan drug is a designation by the U.S. FDA under the Orphan Drug Act confirming that a new drug in development is intended to treat a rare disease, defined as those that affect fewer than 200,000 persons in the United States.  Sponsors of drugs granted orphan designation qualify for tax credits and marketing exclusivity incentives.

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  Media:NephRx Corp.

GendeLLindheim BioCom PartnersPhilip A. Long

Barbara Lindheim (269) 838-4785

(212) 918-4650

SOURCE NephRx Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. BioSpecifics Technologies Corp. Reports Second Quarter 2008 Financial Results
2. InstaCare Corp. Continues Turnaround & Reports 291% Revenues Increase in 2Q 2008
3. ThermoGenesis Corp. to Announce Fourth Quarter and Year End Results for Fiscal 2008 on September 9, 2008
4. BioSpecifics Technologies Corp. Buys Down Royalties for Peyronies Disease
5. Aegis Analytical Corp. Showcases Discoverant at Inaugural Venture Capital in the Rockies Fall
6. BioElectronics Corp. Announces $400,000 in New Orders From the Middle East
7. BioSpecifics Technologies Corp. Announces Appointment of Dr. Matthew Geller to Board of Directors
8. Cantel Medical Corp. To Hold Conference call to Discuss Fourth Quarter and Fiscal 2008 Results
9. Helix BioPharma Corp. Announces Fiscal 2008 Results
10. Sharps Compliance Corp. Announces Appointment of John R. Grow as President and Chief Operating Officer
11. ThermoGenesis Corp. to Announce First Quarter Fiscal 2009 Results on November 6, 2008
Post Your Comments:
(Date:11/27/2015)... November 27, 2015 ... popularity of companion diagnostics is one of ... market with pharmaceutical companies and diagnostic manufacturers ... tests. . --> ... report on global cancer biomarkers market spread ...
(Date:11/25/2015)... 2015 --> ... - 2020 report analyzes that automating biobanking workflow ... in long-term samples, minimizing manual errors, improving the ... manual errors such as mislabeling or inaccurate sample ... plays a vital role in blood fractionation, DNA ...
(Date:11/25/2015)... BRUSSELS , November 25, 2015 ... in cat and human plaque and pave the way for ... health problems in cats     ... the most commonly diagnosed health problems in cats, yet relatively ... until now. Two collaborative studies have been conducted by researchers ...
(Date:11/25/2015)... QUEBEC CITY , Nov. 25, 2015 /PRNewswire/ ... "Company"), affirms that its business and prospects remain ... , Zoptrex™ (zoptarelin doxorubicin) recently received DSMB ... program to completion following review of the final ... met Phase 2 Primary Endpoint in men with ...
Breaking Biology Technology:
(Date:11/10/2015)... LONDON , Nov. 10, 2015 /PRNewswire/ ... segmented on the basis of product, type, ... segments included in this report are consumables, ... this report are safety biomarkers, efficacy biomarkers, ... in this report are diagnostics development, drug ...
(Date:11/9/2015)... 09, 2015 ... the "Global Law Enforcement Biometrics Market ... --> ) has announced the ... Biometrics Market 2015-2019" report to their ... ( ) has announced the addition ...
(Date:11/4/2015)... November 4, 2015 --> ... report published by Transparency Market Research "Home Security Solutions Market ... Forecast 2015 - 2022", the global home security solutions market is ... by 2022. The market is estimated to expand at ... 2015 to 2022. Rising security needs among customers at ...
Breaking Biology News(10 mins):